Basic Research Handbook City of Hope: March 2015

Download as pdf or txt
Download as pdf or txt
You are on page 1of 90

City of Hope

Basic Research Handbook

March 2015
City of Hope Basic Research Handbook Page |2

BASIC RESEARCH HANDBOOK

Table of Contents

INTRODUCTION _____________________________________________________________________ 6
ONBOARDING_______________________________________________________________________ 7
NEW HIRE ORIENTATION __________________________________________________________ 8
Organizational Orientation Overview __________________________________________________ 8
Safety Orientation Overview __________________________________________________________ 8
Department Orientation Overview ____________________________________________________ 8
EMPLOYEE HEALTH SERVICES INITIAL ASSESSMENT _________________________________ 9
BUSINESS MANAGER/DIRECTOR ___________________________________________________ 9
IMMIGRATION SERVICES __________________________________________________________ 9
What Our Purpose Is ________________________________________________________________ 9
How We’re Organized _______________________________________________________________ 9
What We Do ______________________________________________________________________ 10
Definitions ________________________________________________________________________ 15
Points to Remember ________________________________________________________________ 15
LABORATORY SPACE ALLOTMENT ________________________________________________ 16
TRANSFERRING A LABORATORY __________________________________________________ 16
Hiring Staff from another Institution __________________________________________________ 16
Transferring/Shipping Animals to City of Hope ________________________________________ 17
Transferring/Shipping Animals from City of Hope ______________________________________ 17
Transfer/Shipment of Equipment ____________________________________________________ 18
Transfer/Shipment of Hazardous Materials____________________________________________ 18
Transfer/Shipment of Research Materials _____________________________________________ 18
Transfer of a Grant _________________________________________________________________ 18
SETTING UP A LABORATORY _________________________________________________________ 19
OCCUPATIONAL SAFETY AND HEALTH DEPARTMENT ______________________________ 20
What Our Purpose Is _______________________________________________________________ 20
How We’re Organized ______________________________________________________________ 20
What We Do ______________________________________________________________________ 20
City of Hope Basic Research Handbook Page |3

RESEARCH FACILITIES AND EMERGENCY PLANNING _______________________________ 23


What Our Purpose Is _______________________________________________________________ 23
How We’re Organized ______________________________________________________________ 23
What We Do ______________________________________________________________________ 23
BIOMEDICAL INSTRUMENTATION SERVICES _______________________________________ 24
What Our Purpose Is _______________________________________________________________ 24
How We’re Organized ______________________________________________________________ 24
What We Do ______________________________________________________________________ 24
INFORMATION TECHNOLOGY ____________________________________________________ 25
What Our Purpose Is _______________________________________________________________ 25
How We’re Organized ______________________________________________________________ 25
What We Do ______________________________________________________________________ 25
E-Mail User Groups ________________________________________________________________ 27
AccessNET________________________________________________________________________ 27
Virtual Private Network (VPN) _______________________________________________________ 27
Information Systems _______________________________________________________________ 27
SHARED RESOURCES, CORES AND SUPPORT SERVICES____________________________31
CORE FACILITIES ________________________________________________________________ 32
What Our Purpose Is _______________________________________________________________ 32
How We’re Organized ______________________________________________________________ 32
What We Do ______________________________________________________________________ 32
LIBRARY SERVICES _______________________________________________________________ 36
What Our Purpose Is _______________________________________________________________ 36
How We’re Organized ______________________________________________________________ 36
What We Do ______________________________________________________________________ 37
CREATIVE SERVICES _____________________________________________________________ 38
What Our Purpose Is _______________________________________________________________ 38
How We’re Organized ______________________________________________________________ 38
What We Do ______________________________________________________________________ 38
GRANTS MANAGEMENT _________________________________________________________ 39
OFFICE OF SPONSORED RESEARCH ________________________________________________ 40
What Our Purpose Is _______________________________________________________________ 40
How We’re Organized ______________________________________________________________ 40
What We Do ______________________________________________________________________ 40
OFFICE OF FOUNDATION RELATIONS _____________________________________________ 51
What Our Purpose Is _______________________________________________________________ 51
How We’re Organized ______________________________________________________________ 51
What We Do ______________________________________________________________________ 52
OFFICE OF FACULTY AND INSTITUTIONAL SUPPORT _______________________________ 54
What Our Purpose Is _______________________________________________________________ 54
How We’re Organized ______________________________________________________________ 54
What We Do ______________________________________________________________________ 54
City of Hope Basic Research Handbook Page |4

OFFICE OF TECHNOLOGY LICENSING ______________________________________________ 55


What Our Purpose Is _______________________________________________________________ 55
How We’re Organized ______________________________________________________________ 55
What We Do ______________________________________________________________________ 55
Points to Remember ________________________________________________________________ 61
RESEARCH FINANCE _____________________________________________________________ 61
What Our Purpose Is _______________________________________________________________ 61
How We’re Organized ______________________________________________________________ 61
What We Do ______________________________________________________________________ 61
COMPLIANCE ____________________________________________________________________ 63
CORPORATE COMPLIANCE OFFICE ________________________________________________ 64
What Our Purpose Is _______________________________________________________________ 64
How We’re Organized ______________________________________________________________ 64
What We Do ______________________________________________________________________ 64
Institutional Official ________________________________________________________________ 65
Conflict Of Interest _________________________________________________________________ 65
RESEARCH PROTECTIONS ________________________________________________________ 65
What Our Purpose is _______________________________________________________________ 65
How We’re Organized ______________________________________________________________ 66
What We Do ______________________________________________________________________ 66
Compliance Committees Under Research Protections ___________________________________ 66
Institutional Animal Care and Use Committee (IACUC) ____________________________ 66
Institutional Biosafety Committee (IBC) _________________________________________ 68
Occupational Safety and Biohazard Committee (OSBC) ____________________________ 71
Stem Cell Research Oversight (SCRO) Committee ________________________________ 72
Institutional Review Board (IRB) ________________________________________________ 73
RADIATION SAFETY COMMITTEE (RSC) ____________________________________________ 79
ONGOING ________________________________________________________________________ 80
OFFICE OF ACADEMIC AFFAIRS ___________________________________________________ 81
What Our Purpose Is _______________________________________________________________ 81
How We’re Organized ______________________________________________________________ 81
What We Do ______________________________________________________________________ 81
FINDING ADDITIONAL LABORATORY PERSONNEL __________________________________ 82
Graduate School Students ___________________________________________________________ 82
Summer Students __________________________________________________________________ 82
Human Resources Hiring Department ________________________________________________ 82
COMMUNICATIONS _____________________________________________________________ 84
What Our Purpose Is _______________________________________________________________ 84
How We’re Organized ______________________________________________________________ 84
What We Do ______________________________________________________________________ 84
City of Hope Basic Research Handbook Page |5

EMPLOYEE HEALTH SERVICES ____________________________________________________ 85


What Our Purpose Is _______________________________________________________________ 85
How We’re Organized ______________________________________________________________ 85
What We Do ______________________________________________________________________ 85
TRAVEL _________________________________________________________________________ 87
CLOSING A LABORATORY ________________________________________________________ 88
ACKNOWLEDGEMENTS __________________________________________________________ 89
FEEDBACK _______________________________________________________________________ 90
City of Hope Basic Research Handbook Page |6

INTRODUCTION

I am pleased to provide a copy of the Basic Research Handbook. This document represents the
results of several months of work on the part of many members of the Research Operations team and
our colleagues across the City of Hope campus. Substantial time, effort, experience, and expertise
have contributed to this effort and it is my hope that the faculty and operational staff will find it
helpful.

This Handbook is aimed at supporting the COH community involved in the financial or operational
conduct of basic research. It is not my intent for this manual to be read from cover-to-cover like a
book; the goal of this document is to create a useful guidance and reference tool for the COH
research and operational community in accessing both internal and external resources.

I am hopeful that this Handbook will prove to be a “living document” that will be updated over time to
incorporate comments, suggestions, and ideas for best practices from you, as well as to reflect new
knowledge and thereby help assure compliance and efficiency in the basic research setting.

Ashley Baker Lee


Senior Vice President, Research Operations
Beckman Research Institute at City of Hope
City of Hope Basic Research Handbook Page |7

ONBOARDING
Human Resources (HR) initiates the search process to identify the
ideal candidate for a job posting, including a thorough interview
and reference check. The Office of Academic Affairs handles
Professor series recruitment. Once a candidate has been selected,
HR works with the department Business Manager/Director to
begin the onboarding process. This section identifies all the steps
needed to complete this process.
City of Hope Basic Research Handbook Page |8

NEW HIRE ORIENTATION


Recruiting, retaining and developing an excellent workforce is key to implementing City of Hope’s
strategic plan. The institution provides a comprehensive, multi-faceted program of orientation. New
personnel attend Organization Orientation and Safety Orientation on their first day of employment, if
possible, or the next scheduled orientation session available. Newly hired personnel are required to
complete all components of City of Hope Orientation before independently performing their job
duties.

Organizational Orientation Overview

Organizational Orientation assists new personnel in understanding City of Hope’s:

• Organizational history
• Culture
• Mission/vision/values
• Policies and Procedures
• Performance Development and Review Process (PDRP)
• Corporate Compliance Program
• Other work environment information

Safety Orientation Overview

Safety Orientation is comprised of four hours of safety-related presentations (PowerPoint and


videos) that include:

• General laboratory safety


concepts
• Hazard communication
(identification of laboratory
hazards)
• Fire extinguisher training
• Laboratory waste disposal
procedures
• Ergonomic awareness
• Bloodborne pathogens
• General principals of biosafety
• Emergency Preparedness

Department Orientation Overview

The department orientation program assists new personnel in understanding departmental policies
and procedures as well as key job responsibilities.
City of Hope Basic Research Handbook Page |9

EMPLOYEE HEALTH SERVICES INITIAL ASSESSMENT


The Employee Health Services (EHS) Initial Assessment is required of all personnel after accepting a
position at City of Hope. It consists of a brief physical exam, which includes evaluation of the
personnel’s immunization status and, if working in the Medical Center or in the Animal Resource
Center (ARC), a tuberculosis (TB) skin test. These evaluations are required to meet standards set by
regulatory agencies. The personnel’s medical status is reviewed to identify any health issues that
might occur with the new job position. Clearance by EHS is required to begin work.

BUSINESS MANAGER/DIRECTOR
The Business Manager/Director is responsible for the overall management and performance of a
business unit. Management responsibilities include developing and implementing strategic plans,
operating facilities and planning space, as well as overseeing and directing business unit staff to
ensure successful operations. This includes working with other units to ensure organizational goals
are met. Financial responsibilities include implementing and maintaining the annual budgets,
research funding, capital expenditure, approve spending, and ensure profitability for the unit.

Some of the things the Business Manager/Director can do for investigators:

• Consult with Human Resources-Immigration Services (HR-IS) about the right type of
immigration sponsorship
• Consult with the Office of Sponsored Research (OSR) about various funding and spending
requests
• Manage and oversee research spending in consultation with Research Finance (RF) and
Grant Accounting
• Work with Human Resources (HR) when additional personnel are needed for a research
project

IMMIGRATION SERVICES
What Our Purpose Is

To ensure personnel are lawfully employed, City of Hope offers visa assistance and sponsors to
eligible foreign nationals through Human Resources-Immigration Services (HR-IS).

How We’re Organized

Immigration Services is part of the Talent Acquisition department, which is part of Human Resources.

• Call: Extension 37575 or 83872


• Website: http://www.cityofhope.org/visa-services
City of Hope Basic Research Handbook P a g e | 10

What We Do

The following answers to frequently asked questions provides an overview of the assistance available
through Immigration Services.

Does City of Hope sponsor foreign nationals/internationals to work/train/study at the institution?

• Yes. Each foreign national/international will be in a unique situation. The recruiter and the
Business Manager/Director will consult with Human Resources-Immigration Services
(HR-IS) for the right type of immigration sponsorship.

What are the most common types of visas at City of Hope?

• F-1 (Student) – For international students joining or enrolled at the Irell and Manella
Graduate School of Biological Sciences.
• F-1 OPT with EAD (Student/Optional Practical Training with Employment Authorization
Document) – For students who recently graduated from a US college/university that are
allowed a period of training during or after completion of their degree.
• J-1 (Research Scholar/Short-Term Scholar) – City of Hope is only approved for two types
of J-1s: (a) Research Scholar and (b) Short-Term Scholar. The J-1 is reserved for
internationals who are at City of Hope temporarily to perform research/observe/teach. At
City of Hope, this is commonly used for postdoctoral fellows, pre-doctoral fellows and
visiting faculty/investigators/scientists.
• H-1B (Specialty Occupation) – For internationals employed in a regular position at City of
Hope. The international requires at least a bachelor’s degree and the position to be held at
City of Hope must require at least a bachelor’s degree industry-wide (e.g., a Registered
Nurse will not qualify for an H-1B even if City of Hope requires its nurses to have at least a
BSN since industry-wide an AA in Nursing is acceptable). At City of Hope, this is
commonly used for Staff Scientists, Biostatisticians, Research Associates, Information
Technology positions, etc.
• TN (Mexico and Canada Nationals) – This is similar to an H-1B but strictly reserved for
citizens of Mexico and Canada. At City of Hope, this is commonly used for Nurses and
Information Technology positions.

How long does immigration sponsorship take?

Processing of immigration sponsorship is complicated and varies by type of visa, where the foreign
national is coming from, where the foreign national was born, whether the foreign national is in the
United States (US) or outside the US, etc. The recruiter and Business Manager/Director will consult
with HR-IS regarding each candidate’s specific processing time.

Examples:
• J-1 postdoc transferring from another institution may take 1 month with the following
conditions: J-1 is valid, research is in the same category, postdoc is in the United States,
and HR-IS has all necessary information and documents from the department and the
postdoc.
City of Hope Basic Research Handbook P a g e | 11

• H-1B staff scientist transferring from another institution may take 6-8 weeks with the
following conditions: H-1B is valid, staff scientist is in the US, and HR-IS has all necessary
information and documents from the department and the staff scientist.
• New postdoc from China may take at least 3 months with the following conditions: needs
new J-1, HR-IS has all necessary information and documents from the department and
postdoc, and postdoc is subject to administrative processing in the US consulate in China.

What is the process for initiating immigration sponsorship for a foreign national/ international
candidate or personnel?

INSZoom is the web-based, case-processing system used to process visas at City of Hope. To use,
contact the department Business Manager/Director who will most likely already have a log-in name,
password and training to use this system.

Are there limits to the different visa types?

Yes. See the Immigration Sponsorship Guidelines below for reference. Consider the time limits when
sponsoring an international/foreign national.

Is visa approval guaranteed for an international/foreign national?

No. HR-IS cannot guarantee a successful visa application or petition approval from the United States
Citizenship and Immigration Services (USCIS) or the Department of State (DOS).

Once personnel are in the US, what is required for a Sponsoring Employer to maintain an
international/foreign national’s status?

It is important to notify HR-IS of any significant change to an international/foreign national’s


employment, including but not limited to: job duties, job title, salary decrease, transfer to another
department, change in number of work hours a week (i.e., full time to part time or part time to full
time), change in work location (i.e., campus to MAC or campus to Flower), paying entity (i.e., Med
Center to BRI or vice versa), termination, etc. The Department of State and USCIS may conduct site
visits to check employment of visa holders, so it is crucial to keep these agencies informed of changes
to the international/foreign national’s employment/training at City of Hope. Internationals/Foreign
Nationals may lose their US immigration status and City of Hope can be penalized for violations.

Once City of Hope sponsors a foreign national for a visa, can he or she bring family to the US?

Yes. Spouse and children under 21 years of age may apply for a dependent visa.

Can the spouse of that foreign national work or volunteer in a lab at City of Hope?

Only if that person has a valid work authorization or work status, regardless of whether the position is
paid or unpaid. Dependent of J-1, called J-2, may apply for an Employment Authorization Document
(EAD). However, dependents of H-1B and TN are not eligible for EAD. If the spouse wishes to gain
research experience at City of Hope, the spouse should be sponsored for a visa as a principal
applicant, not a dependent.
City of Hope Basic Research Handbook P a g e | 12

IMMIGRATION SPONSORSHIP GUIDELINES

Non-Immigrant Visa Processing Time/


Definition Cost
and Time Limits When to Start
F-1 International Student  If outside the US, allow at  No cost to graduate
Time limit depends on enrolled at Irell and least 3 months for school
time needed to Manella Graduate processing and entry to the  Student pays for visa
complete PhD School of Biological US and SEVIS fees
Sciences  If in the US, allow 1 to 3
months for processing
(depending on previous
immigration status)
F-1/Optional “A recent graduate of a  EAD application prepared  No cost to
Practical Training US college/ university” and submitted by EE department
(OPT) authorized to work using (employee)  EAD - $380 filing fee.
Limit: 12 months (17 an EAD (employment  Can start as long as EAD is Paid for by EE
months more if STEM authorization document) valid
graduate and will be  EAD extension process
working for BRI – an takes at least 3 months
E-verify entity. Not all with USCIS
STEM degree are
eligible, confirm with
HR-IS)
J-1 “Exchange Visitor” in  If in the US, allow at least 3  No cost to
Limit: 5 years Research Scholar or weeks for J-1 transfer department (J-1 forms
Short-Term Scholar process done in-house)
categories (i.e., Post-  If outside the US, allow at  If outside the US, EE
docs, Pre-docs, Trainees, least 3 months for pays visa and SEVIS
Foreign MD Trainees) processing and entry to the feed
 Paid or unpaid US
training position
H-1B “Specialty Occupation” –  If in the US and presently  Approximately
Limit: 6 years  Position requires holds H-1B, 6-8 weeks $2,425 via regular
minimum bachelor’s processing for EE to start processing
degree and FN has at  If outside the US or a  Approximately
least a bachelor’s. change of status (i.e. J-1 to $2,425 + $1,225 =
 Paid regular H-1B, OPT to H-1B), allow $3,650 via premium
employment position 7-9 months processing for processing
EE to enter the US or 4-5  Use of outside
months via premium immigration attorney
processing and filing with USCIS
TN “Citizens of Mexico and  Allow 2-3 weeks  No cost to
Limit: indefinite with Canada” processing department (TN
proof of non-  Position on NAFTA  EE should travel to a US packet done in-house)
immigrant intent list border or a US airport.  EE pays for TN border
 Paid position Otherwise filing with or visa fees
USCIS will take 7-9
months.
City of Hope Basic Research Handbook P a g e | 13

What should be done when an international/foreign national personnel and/or colleague requests a
reference letter for a self-petition green card petition?

Foreign nationals apply for US Permanent Resident status because their non-immigrant H‐1B, O‐1 or
J‐1 status is temporary with specific time limits and restrictions. One restriction is not being eligible to
apply for Federally‐funded research opportunities. In addition, some positions are not eligible for
company-sponsored US Permanent Resident applications, such as a Postdoctoral Fellow. Refer to the
table on the following page to determine if the personnel requesting the letter qualifies for a Self-
Petition Green Card.

Reference letters may be requested for


self-petition US Permanent
Resident/green card applications on
behalf of foreign national employees or
colleagues from other US institutions.

What are guidelines for writing reference


letters for self-petition green card
petition?

1. A standard reference letter


consists of three parts:
a. paragraph on your
qualifications;
b. section describing the foreign
national’s credentials, and;
c. description of contributions the
foreign national has made to
the field. The purpose of this
description is to provide proof
that this person is a top
researcher/scientist in his/her
field and therefore qualifies for
a self‐petition National Interest
Waiver or Exceptional Ability.
2. Carefully review the letter for
accuracy of the information.
3. Provide factual information only. Do not exaggerate or embellish. As a representative of City
of Hope and the Beckman Research Institute, it is important that you do not overstate the
requestor’s credentials to ensure that the US Citizenship and Immigration Services (“USCIS”)
continues to view our organization as a credible employer with highly qualified foreign
national researchers and scientists.
4. Do not feel obliged to sign a reference letter prepared by the foreign national and/or his/her
immigration attorney. You can make edits as you feel needed.
City of Hope Basic Research Handbook P a g e | 14
City of Hope Basic Research Handbook P a g e | 15

Definitions

• STEM – Science, Technology, Engineering and Mathematics


• HR-IS – City of Hope’s Human Resources – Immigration Services
• USCIS – United States Citizenship and Immigration Services
• SEVIS – Student and Exchange Visitor Information System
• Premium Processing – Expedited processing at USCIS for H-1Bs for an additional fee
• NAFTA – North American Free Trade Agreement

Points to Remember

• Each international/foreign national will have a unique situation. The above table is only a
guide. Always consult HR-IS for the best immigration sponsorship strategy
• Always consult HR-IS for updated fee schedule; fees are subject to change
• Due to time limits of each non-immigrant visa type, always consult HR-IS for next steps
• Due to time limits of each non-immigrant visa type, also consider the possibility of COH-
sponsored US permanent resident/green card application for every international/foreign
national hired

Please note : City of Hope is committed to hiring US citizens whenever possible.


City of Hope Basic Research Handbook P a g e | 16

LABORATORY SPACE ALLOTMENT


Space commitments are only made with investigators in the Professor Series or equivalent. Square
footage of space is determined based on the level of the Professor. The allotments are subject to the
terms of the faculty offer letter and are adjusted based on varying factors such as the type of work
being done in the laboratory and the layout of the building:

• Full Professor is allotted approximately 1500-2000 sq ft.


• Associate Professor is allotted approximately 1000-1500 sq ft.
• Assistant Professor is allotted approximately 500-1000 sq ft.

The space allotment may also be adjusted


commensurate with grant funding. Shared space is part
of total space allotment. Shared space is determined
per building and then divided among the number of
investigators housed in that building Office space (also
known as “dry-lab”) for staff non-principal investigators
(staff scientists, assistance research scientists,
associate research scientists, research scientists) is
provided when available and is counted in the total lab
space allocation. Some buildings also have cubicle
space for postdoctoral fellows. Sitting space for
students/trainees and research associates is within the
principal investigator’s lab space. A principal
investigator’s office and administrative support are not
part of the total lab space.

The location of the laboratory is determined by the


recruitment entities. Request for additional space
should be directed to the Chairperson of the
department. If needed, the Beckman Research Institute Director and/or the Beckman Council can
make a final determination based on particular criteria.

Ultimate authority for laboratory research space resides with the Beckman Research Institute (BRI)
Director.

TRANSFERRING A LABORATORY
Hiring Staff from another Institution

When a research project is transferred from another institution, contact the department Business
Manager/Director to discuss the possibility of City of Hope hiring staff currently working on the
project.
City of Hope Basic Research Handbook P a g e | 17

Transferring/Shipping Animals to City of Hope

Transferring or shipping ongoing animal studies to City of Hope requires close communication and
coordination between investigators and City of Hope Beckman Research Institute (BRI). Animal
based studies may only be performed under an animal use protocol approved by the City of Hope
Institutional Animal Care and Use Committee (IACUC).

Investigators must also contact the Division of Comparative Medicine (DCM) prior to shipping
animals to City of Hope. The DCM’s Animal Resources Center (DCM/ARC) will provide assistance
with shipping and receiving, quarantine, animal health assessment and animal holding space. The
animal transfer process begins when the transferring investigator contacts the DCM/ARC shipping
coordinator. An Animal Shipping Record form (available on the DCM secure Intranet site forms
section; see E-mail User Groups regarding
access) will be provided to the transferring
investigator requesting animal health history,
strain information, veterinary contacts at the
sending institution, breeding information and
billing account numbers. This information will
be reviewed by the DCM veterinary staff prior
to a decision to approve a transfer.

Investigators transferring breeding colonies to


City of Hope are strongly advised to utilize the
DCM’s core breeding service. The DCM
breeding team works with investigators to
determine breeding strategies that meet
production goals and performs all animal manipulation including mating, weaning, tissue biopsy,
animal identification and recordkeeping.

All animals arriving from non-commercial (institutional) sources are placed in a quarantine holding
room. While in quarantine, they will receive preventive treatment for pin worms and fur mites. They
will also be assigned a dedicated sentinel animal that will be in direct contact with dirty bedding from
the animals being transferred. Sentinel animals will be euthanized and subjected to diagnostic testing
6-8 weeks after exposure. While in quarantine, the animals are unavailable for experimental
purposes. If the quarantined animals are an ongoing breeding colony and must be mated because of
aging or genetic issues, breeding maybe arranged while in quarantine. Upon receipt of the sentinel
diagnostic report, animals will be released for use and the appropriate animal holding room
assignment will be made.

Transferring/Shipping Animals from City of Hope

Any shipment of City of Hope owned animals to another institution must be described and approved
in the City of Hope IACUC-approved protocol and approved by the receiving institution’s IACUC.
Receiving institutions must have a current Office of Laboratory Animal Welfare (OLAW) Letter of
Assurance on file and current accreditation by AAALAC International is strongly preferred.
City of Hope Basic Research Handbook P a g e | 18

Animal shipping arrangements must be made through the DCM/ARC shipping coordinator. An
Animal Shipping Record form (available on the DCM secure Intranet site forms section) must be
completed and returned to the DCM/ARC shipping coordinator prior to shipping any animals. The
DCM/ARC shipping coordinator will provide any health history information required by the receiving
institution, coordinate shipping and arrange delivery by laboratory animal transport specialists.

Animals may be transported locally for procedures such as imaging in private vehicles if described in
an IACUC approved protocol. Animals must be transported in covered, secure transport containers,
provided with feed and hydration adequate for the duration of the trip and procedure, and maintained
in a climate controlled environment that meets the appropriate optimal temperature range described
in the National Research Council (NRC) Guide for the Care and Use of Laboratory Animals.

Transfer/Shipment of Equipment

Equipment to be transferred and shipped needs to be tagged for the City of Hope asset registry. The
investigator, Business Manager/Director and Research Finance will coordinate this transfer.

Transfer/Shipment of Hazardous Materials

An infectious substance is regulated as a hazardous material under the United States Department of
Transportation’s (DOT’s) Hazardous Materials Regulations. The HMR apply to any material DOT
determines is capable of posing an unreasonable risk to health, safety and property when transported
in commerce. An infectious substance must conform to all applicable HMR requirements when
offered for transportation or transported by air, highway, rail or water.

Anyone wishing to provide materials covered under this rule to investigators outside of City of Hope
must notify the Occupational Safety and Health Department (OSHD) for guidance and assistance in
shipping this material away from City of Hope. Shippers must be properly trained by OSHD before
shipping any hazardous material.

Transfer/Shipment of Research Materials

Research materials that are not available for purchase from suppliers are typically exchanged
between scientists using Material Transfer Agreements (MTAs). The Office of Technology Licensing
(OTL) has implemented procedural improvements to expedite MTAs.

Transfer of a Grant

The Office of Sponsored Research (OSR) will assist in the transfer of grants from the previous
institution.
City of Hope Basic Research Handbook P a g e | 19

SETTING UP A LABORATORY
It is a strategic goal at City of Hope to build processes that are
safe, efficient and effective in bringing about cures for cancer and
other diseases. One such effort is assisting new investigators in
getting their laboratories up and running quickly so they may
begin their research with minimal delays. This section describes
the processes new investigators should follow as they setup their
laboratory at City of Hope.
City of Hope Basic Research Handbook P a g e | 20

OCCUPATIONAL SAFETY AND HEALTH DEPARTMENT

What Our Purpose Is

The Occupational Safety and Health Department is charged with developing and implementing
policies, procedures and specific programs to eliminate causative risk factors from the workplace.
This includes being a resource assisting directors, managers and supervisors to:

• Promote a safer / healthier


work environment
• Identify and evaluate actual
and potential risks
• Train and educate staff in
safety and health
• Review and interpret
accident Investigation
Reports
• Identify areas of economic
loss to the corporations
• Review safety policies and
procedures to ensure they
are current and responsive to
the needs of our clients
• Measure the effectiveness of the program and determine cost reduction strategies.

OSHD provides expertise in areas of biological safety, chemical safety, radiation safety, ergonomics,
hazardous waste disposal and emergency preparedness, as well as safety training.

How We’re Organized

• Call: Extension 63375


• Email: #[email protected]
• Website: http://www.coh.org/safety/Pages/default.aspx
• Location: Buena Vista Facilities Logistics and Support Hub (FLASH) Building

What We Do

As stewards of City of Hope’s Safety Culture, the Occupational Safety and Health Department
ensures a safe and healthy environment for our staff, patients and visitors by providing excellent
programs and services, delivered with integrity and compassion. The Department’s vision is that all
staff at City of Hope be aware of the potential hazards they may encounter, possess the skills to
safely handle hazardous materials and equipment, respond promptly and properly in the event of an
accident or emergency and make safety part of their daily work. The Department’s goal is to ensure
all City of Hope safety programs are in the 90th percentile when compared to other medical centers.
City of Hope Basic Research Handbook P a g e | 21

Laboratories present unique hazards and must be handled properly and carefully to prevent
catastrophic events that cause serious injury or property damage. The Occupational Safety and
Health Department offers numerous programs for staff performing basic laboratory research
including:

• Introductory Laboratory Safety


Training
• Refresher training
• Specific Hazard Training
• Standard Operating
Procedures
• Job Hazard Analysis
• Ergonomic Assessments
• Accident Investigations
• Maintenance of Safety Data
Sheets
• Maintenance of Chemical
Inventories
• Laboratory Inspections
• Review of laboratory protocols and procedures

Evaluation of Skills and Experience Specific to a Research Project

The Occupational Safety and Health Department supports research efforts through its involvement in
several research oversight and compliance committees such as:

• Radiation Safety Committee (RSC)


• Institutional Biosafety Committee (IBC)
• Occupational Safety and Biohazards Committee (OSBC)
• Institutional Animal Care and use Committee (IACUC)

OSHD staff serves on these committees and are directly responsible for the administration of the
Radiation Safety Committee. To speed up the review of research protocols OSHD staff pre-review
protocols to make sure the applications are complete before review by the committees. This reduces
the likelihood of delays in the approval process and allows the committees to focus on important
safety and regulatory concerns instead of administrative issues. This process has greatly sped up the
approval process and improved the quality of the research protocols. How each of these and other
research compliance committees operate is described in the Research Protections section.

Safety Training

The City of Hope and Beckman Research Institute’s (COH/BRI) commitment to safety is stated in the
Injury and Illness Prevention Program (IIPP). Providing safety training and the responsibility of
supervisors are major components of this program. The Beckman Research Institute has a mandatory
training program, based on federal, state and local regulations, which requires training for all
laboratory personnel to ensure that they are qualified to work with and handle biological agents,
City of Hope Basic Research Handbook P a g e | 22

hazardous chemicals, sharps, radioactive substances and other hazardous materials and equipment
found in the laboratory environment. Employees and Supervisors must maintain safety training
records. OSHD does not maintain individual employee safety training records, but they can be
accessed through the Human Resources PeopleSoft database.

Introduction to Laboratory Safety Class: Seven hours of training covering all aspects of laboratory
safety. The class is required for all new laboratory workers and is designed to educate them on how
to integrate safety awareness into all laboratory activities. Material will be taught with significant use
of case-studies, exercises, discussions and hands-on practice. Knowledge is demonstrated through a
final lab practicum. Training includes, but is not limited to, bloodborne pathogen training, hazardous
chemical training an introduction to radioactive materials as well as case studies in laboratory safety

Web-based training programs for areas not covered during new hire orientation (such as cart
safety, infectious agent transport) are available. Small vignettes may be produced and placed on the
OHSD website demonstrating the proper use of specific lab equipment and procedures. Additional
interactive, web-based training will be developed to address all aspects of laboratory safety.

Classroom Refresher Training - Review of Laboratory Safety: This is an abridged version of the
Introduction to Laboratory Safety Class. Annually, after receiving initial training, personnel must take:

• Lab Safety Refresher Training (as assigned)


• Radiation Safety Refresher Training (if assigned to an active Radioactive Material Use Permit)
• Bloodborne Pathogen Refresher Training (if working with human blood, body fluids or tissue in
the laboratory or any pathogen that is infectious to humans via blood, body fluids or tissues)

Participation of OSHD personnel in lab meetings:


Annually, an OSHD staff member may participate in a
scheduled lab meeting to give brief refresher safety
training and be available to answer specific safety-
related questions.

Ad Hoc Training may be requested on specific issues


communicated by laboratory staff.

Radiation Safety Committee (RSC)

The Radiation Safety Committee (RSC) is managed by


OSHD. The RSC is responsible for review of all uses
of radioactive materials at the City of Hope. The
RSC’s purview, training requirements, submission
process and review process are covered in the
Compliance section of this handbook.
City of Hope Basic Research Handbook P a g e | 23

RESEARCH FACILITIES AND EMERGENCY PLANNING


What Our Purpose Is

Research Facilities and Emergency Planning provides support to investigators that includes space and
equipment, maintenance, repair, personnel moves, safety, and campus projects. In addition our office
supports the Beckman Research Institute in its emergency planning and disaster response
management.

How We’re Organized

Research Facilities and Emergency Planning is run by a manager in Basic Research Operations.

• Call: Extension 62589


• Page: (626) 423-5679
• FAX: (626) 301-8136

What We Do

The Laboratory Compliance


questionnaire covers basic
laboratory activities and helps to
determine the skill and experience
level of personnel. Based on answers
provided to the questionnaire, the
investigator/research staff will be
contacted if further training is
required. Individual personnel will
be directed to web-based modules
covering both general laboratory
safety concepts as well as specific
modules that address chemical
safety, radioactive substance use and biosafety.

As part of the support provided to investigators, Research Facilities and Emergency Planning has
established “ shared” equipment areas throughout the institution which house various pieces of
basic research laboratory equipment such as centrifuges, plate readers and other data gathering
instrumentation for all investigators to use. Posting in these areas identifies which equipment is
“shared” and provides contact information.

In addition, there are two facilities similar to the research cores, the PCR Facility and the Imaging
Facility, which are free of charge to the user. In the case of the PCR facility, required training sessions
are scheduled on a regular basis.

An investigator needing to use equipment that is department specific should seek the advice of a lab
member that has been properly trained in the use of the identified equipment. When this is not
City of Hope Basic Research Handbook P a g e | 24

possible, the investigator should contact his or her supervisor in order to arrange for proper training.
If training cannot be arranged within the department, the user can place a request to Biomedical
Instrumentation Services (BIS).

BIOMEDICAL INSTRUMENTATION SERVICES


What Our Purpose Is

Biomedical Instrumentation Services (BIS) provides equipment repair and maintenance support and
plays an important role in meeting regulatory and other organizational requirements. BIS also
arranges training on shared equipment.

How We’re Organized

Biomedical Instrumentation Services (BIS) is part of Facilities Maintenance Services.

• Call: Facilities HelpDesk – Extension 32245


• Hours: Monday - Friday 7:00 a.m. - 4:30 p.m.
• After Hours Emergencies: Call the PBX office (Extension 55) to have the BIS On-Call
Staff paged. Be sure to leave contact information and reason for call
• BIS Service Request: http://facprod.City of Hope.org/Eforms/Forms/BISRequest.aspx
• Website: http://www.coh.org/bis/Pages/default.aspx

What We Do

• Oversight of equipment repair and


service
• Scheduled equipment inspections
• Safety inspections for new equipment
and devices obtained for short-term
use
• Maintaining an equipment inventory
and service documentation
• Pre-purchase evaluations and
recommendations
• Equipment service contract review
and processing
• User support and training

When needed, an investigator may call BIS to


arrange training on shared equipment or to
request contact information for appropriate
vendor support.
City of Hope Basic Research Handbook P a g e | 25

INFORMATION TECHNOLOGY
What Our Purpose Is

Information Technology Services (ITS) ensures that investigators and staff have the information
technology tools and infrastructure necessary to carry out City of Hope’s mission. ITS provides the
resources that enable leading-edge research and improved productivity.

How We’re Organized

Research Computer Services (RCS) is responsible for coordinating all aspects of IT services for the
research community at City of Hope. Other areas covered by ITS include information security,
wireless services, access to City of Hope computer systems, systems development, training,
equipment support and other technical services.

• Call: ITS HelpDesk -Extension 64357


• Request for Service (RFS): https://coh.secure.force.com/login
• E-mail: [email protected]
• Website: http://www.coh.org/its/Pages/default.aspx

What We Do

Services provided by Research Computer Services (RCS) include requests for new research
computers, replacement of research computers, advice on computer-related purchases, and software
purchases, licensing and installation.

Standard Software Provided at No Cost

• Microsoft Windows Operating System


• Microsoft Office Pro (Word, Excel, PowerPoint, Outlook, Access)
• Anti-virus software
• Cisco VPN Client
• Credant encryption program
• Endnote

This software is provided on computers assigned to personnel for individual use. It is not provided
free on computers that are purchased for general lab or shared use. It is not provided free on
computers provided directly by vendors to run lab equipment.

File and Data Storage

ITS maintains a large system for file storage and special systems for very large data storage. A
request to access these systems is submitted through AccessNET.
City of Hope Basic Research Handbook P a g e | 26

Additional software/Resources Available at No Cost If Needed

• HopeBoard (Learning Management System)


• ChemBioOffice
• ImagePro
• RedCap

Software available on Citrix

To gain access to Citrix an AccessNET request will need to be submitted and approved. The
following software is available on Citrix and is not installed on individual computers:

• Graphpad Prism
• Transfac
• Nexus
• CLCBio Workbench
• Genomics Workbench
• Ingenuity Pathways
• Matlab
• Partek
• NextGene
• Genome Studio

Use of the above software may require


chargeback.

Purchasing Other Software

To purchase software not listed above, request a quote by completing a Request for Service (RFS)
online or by calling the ITS HelpDesk (extension 64357). In general, such requests should come from
individuals in supervisory positions. Once the software is received, request installation using the
same ITS Helpdesk system.

Additional Services

Contact Research IT for:

• Programming
• Training
• Troubleshooting
• Assistance in determining needs and required specifications for computer equipment
and/or software included in grant proposals; involving Research IT early in the process is
recommended
City of Hope Basic Research Handbook P a g e | 27

ITS maintains a High Performance Computing (HPC) system and a General-Purpose Computing on
Graphics Processing Units (GPGPU) system for heavy analytical processing. For questions or access
to either system, contact Research IT.

E-Mail User Groups

All investigators need to have their e-mail listed in the #BRI user group in order to gain access to
secure SharePoint sites such as the Department of Comparative Medicine, the Institutional Animal
Care and Use Committee (IACUC), and Stem Cell Research Oversight (SCRO) Committee, as well
as, to receive announcements of lecture series, research equipment training sessions, new resources
and services available, changes in research-related procedures and policies and other information of
interest to investigators. In order to be added, call the ITS HelpDesk (extension 64357).

AccessNET

AccessNet is used to request and monitor personnel access to various City of Hope information
systems. To use the system, go to the AccessNet page.

Depending on role, the following functions are available:

• Request username and password for available systems.


• Request password reset for available systems.
• View list of available systems.
• View list of current system access.
• Request access for another personnel.
• View list of current system access for another personnel.
• Process requests for access to systems that the personnel administers.
• Modify system information descriptions.

Virtual Private Network (VPN)

The Virtual Private Network (VPN) Online allows City of Hope personnel to connect to City of Hope's
Intranet, File Servers, and E-mail using approved web browsers. VPN allows occasional and frequent
telecommuters to connect to the City of Hope network through the Internet using any internet
connection in a secure encrypted format. Access to VPN is requested through AccessNET.

Information Systems

ECRT (Electronic Certification and Reporting Technology)

As recipients of federal research funding, City of Hope is required to maintain after-the-fact


personnel activity certification for the purpose of properly allocating salary charges and effort to
federal projects. The City of Hope extends the effort reporting requirement to all sponsored projects.
ECRT (Electronic Certification and Reporting Technology) is City of Hope’s on-line effort reporting
tool that is used to facilitate the process of effort reporting.
City of Hope Basic Research Handbook P a g e | 28

• Access ECRT from the City of Hope home page or the OSR home page, which includes the
ECRT calendar, login, FAQ, policies and procedures, tutorials and reference materials.
• ECRT login: same Username and Password as the City of Hope login.
• For assistance, contact [email protected].

EHS Assistant (Employee Health and Safety Assistant)

The Occupational Safety and Health Department has an information system called the EHS Assistant.
This system allows staff to perform many key tasks including managing Radiation Use Permits,
managing chemical inventories, requesting hazardous waste pickups, requesting ergonomic
assessments, accessing injury reports and reviewing and responding to facility inspection findings.

• Access EHS from EHS Assistant Login.


• The EHS webpage includes troubleshooting tips for users.

Enterprise Resource Planning (ERP)

Enterprise Resource Planning (ERP) integrates information across multiple functional areas, including
Finance, Grants, Human Capital Management (HCM) and Supply Chain Management (SCM). ERP
facilitates the flow of data between these functions and across the City of Hope organization,
providing a central repository for information shared by several ERP modules. Requisitions, expense
reimbursement requests, check requests and workflow approval are all done through ERP.

• Access ERP from ERP PeopleSoft NEW with the City of Hope username and password.
• The ERP Webpage provides instructional tools for completing tasks in PeopleSoft.
• For assistance, contact #[email protected].

iLab (Core Facility Management software)

iLAB is an online system designed to streamline the process of ordering and billing for core facility
service requests. iLab is intended to increase core facility utilization and awareness, improve core
financial management, and enhance core user experience. Specific features include:

• A search feature for all cores across the institution that ensures researchers can find all
institution-supported resources and services available to them in one central location.
• One consistent interface for searching resources, requesting services and updating project
progress.
• The ability to view core landing pages from outside the City of Hope Intranet, allowing
researchers external to the institution to view available services.
• The ability for core facilities to automatically generate recharges and invoices and post
charges directly to the general ledger, eliminating data re-entry and improving data accuracy.

The following core facilities are on iLab with more cores to be added in the future:

• Analytical Cytometry
• Animal Tumor Model Program
City of Hope Basic Research Handbook P a g e | 29

• Clinical Immunobiology Correlative Studies


• Design and Fabrication Lab
• Electron Microscopy
• Integrative Genomics
• Light Microscopy
• Mass Spectrometry
• Small Animal Imaging Core
• Survey Research
• Transgenic/Knockout Animal Program
• Veterinary Pathology Program
• X-Ray Crystallography

To request access to the iLab system:

• Access https://coh.ilabsolutions.com with the City of Hope username and password.


• Upon successful authentication, complete the registration form by selecting the appropriate
PI/lab from the pull-down list and providing a phone number.
• Submit the completed registration form to notify the department Business Manager/Director
of the iLab membership request.
• An email with basic instructions on using the system will be sent, however, orders cannot be
placed until the iLab request has been approved and cost centers have been assigned by the
Business Manager/Director.

Please note:

• Payment information must be supplied for all reservations and/or requests when working
with the core facilities. Contact the Business Manager/Director for appropriate information.
• iLab works best in Firefox or Chrome browser.
• For assistance, contact [email protected].
• For detailed information on standard cores, see basic manual.
• For detailed information on scheduling cores, see scheduling manual.

iRISTM (Integrated Research Information


Systems)

iRISTM provides investigators with a


framework to electronically submit and track
information regarding research projects at
City of Hope as required by the following
entities:

• Institutional Review Board (IRB)


• Cancer Protocol Review and
Monitoring Committee (CPRMC)
• Protocol Review and Monitoring
Committee (PRMC)
City of Hope Basic Research Handbook P a g e | 30

• Data and Safety Monitoring Committee (DSMC)


• Office of Clinical Trial Finance (OCTF)
• Biospecimen Repository Committee (BR)
• Office of IND Development and Regulatory Affairs (OIDRA)
• Conflict of Interest and Commitment Committee (COICC)
• Institutional Animal Care and Use Committee (IACUC)
• Stem Cell Research Oversight Committee (SCRO)

Additional modules are being configured for:

• Institutional Biosafety Committee (IBC)


• Occupational and Biohazards Committee (OSBC)
• Radiation Safety Committee (RSC)

Submissions are automatically routed electronically, either sequentially or simultaneously, to the


appropriate committee(s). This approach eliminates the need for duplicate data collection and
provides real-time tracking of how a project is progressing through regulatory and other review at
City of Hope. iRISTM allows research staff to initiate, review, edit and version submission applications
and associated documents. Electronic signature, role-based security access and transaction auditing
facilitates 21 CFR Part 11 compliance.

• Use AccessNET to request access.


• Access https://iris.coh.org with the City of Hope username and password.
• For training or other assistance, contact extension 3-IRIS(x34747) or e-mail
[email protected].

MediTract

City of Hope enters into many different kinds of transactions with outside parties that create
obligations either on the part of City of Hope or the outside party — whether to receive or spend
funds, provide or receive goods or services, or otherwise commit resources. City of Hope’s
standardized contract management system is called MediTract. MediTract is also the depository for
all electronic copies of all grants and progress reports. MediTract is housed in the legal department.

Use the Request for MediTract access to obtain a login for the MediTract website.

Processing steps for using MediTract:

• Obtain proposed contract from vendor or use an approved City of Hope contract template
• Enter the contract into Workflow in MediTract to obtain the approval of the appropriate
personnel, including the Authorized Employee (AE) per the Signature Authority/Hierarchy
Policy and Legal, if Legal review is required (see Contracts Exempt From Legal Review).
• Print the Workflow Summary Page (“printer friendly”) to include in the Contract Package.
• Send the contract to the vendor for signature. If the vendor make changes to the City of
Hope approved template, the agreement information workflow will need to be submitted
and legal department’s approval will need to be obtained.
• Make sure contract is signed by an AE(s) for City of Hope.
City of Hope Basic Research Handbook P a g e | 31

SHARED RESOURCES, CORES AND


SUPPORT SERVICES

City of Hope shared resources offer access to a wide array of


cutting-edge technologies, high-end instrumentation, technical
support and training needed to conduct high-quality research.
These shared resources perform a highly valuable role in
facilitating basic, clinical and translational research. Other shared
resources include Library Services and Creative Services. This
section describes City of Hope entities that provide services to
investigators and their staff, postdoctoral fellows and graduate
students.
City of Hope Basic Research Handbook P a g e | 32

CORE FACILITIES
What Our Purpose Is

To facilitate scientific progress, City of Hope provides investigators and their laboratory teams access
to sophisticated support services and state-of-the-art equipment through many core facilities.

How We’re Organized

Core directors and lab personnel are highly trained experts in their field who provide technical
expertise, consultation, and training.

• Website: http://www.cityofhope.org/research/support/Pages/shared-resources.aspx:

What We Do

The following is a summary of the services provided by the scientific cores that pertain to basic
research:

• Analytical Cytometry Core (ACC) Facility provides investigators with high-quality flow
cytometry instrumentation, as well as expertise in analyzing and/or sorting sample
populations of interest via interpretation of their physical, fluorescent and/or light-scattering
properties. Request service using iLAB.
• Analytical Pharmacology Core
Facility (APCF) conducts
pharmacokinetic and
pharmacodynamic studies for
both chemotherapy clinical
trials and peer-reviewed
preclinical studies. Request
service using iLAB.
• Animal Resources Center
(ARC) Super Core is
responsible for the care and use
of animals in research and
teaching programs at the City
of Hope/Beckman Research
Institute and the facilities in
which the animals are housed.
Services provided include the procurement of animals and animal husbandry supplies,
provision of veterinary medical care, animal care and use, training, use of ARC surgical
facilities and surgical support program, polyclonal antibody production program, rodent
breeding colony core program, and technical support services.
City of Hope Basic Research Handbook P a g e | 33

- Animal Tumor Model Program (ATMP) supports in vivo drug therapeutic


efficacy assessment, drug pharmacokinetic, pharmacodynamic, toxicological and
pathological studies, teratoma formation assays, establishment of primary tumor
xenografts, alive tumor tissue banking as well as in vivo-related procedure training,
protocol documentation and grant applications. Request service using iLAB.
- Transgenic/Knockout Animal Program (TKAP) covers all procedures utilized in
the start-up phase of producing genetically engineered mouse models.
Investigators utilizing the core protocol are free to focus on the experimental use of
animals rather than the production of models. The shared resource provides a
range of production-related services including embryo transfer re-derivation and
cryopreservation of strains. Request service using iLAB.
- Veterinary Pathology Program (VPP) provides research pathology, diagnostic
pathology (to assess research-related morbidity or mortality), necroscopy and/or
tissue collection and trimming, and toxicology/toxicologic pathology consultation.
Request service using iLAB.

• Bioinformatics Core (BIC) Facility provides investigators with high-throughput biological


data analysis tools, data management, unified cyber-infrastructure, training, as well as
trained staff working within a multidisciplinary team to facilitate experimental design,
information management, data integration, annotation, dissemination and visualization.
BIC actively supports Image Analysis, Genomic Analysis, Computer-Assisted Molecular
Design, and Molecular Imaging and provides Laboratory Information Management System
(LIMS) support for user data and software support for BIC subscribers.
• Biostatistics Core Facility (Information Sciences) is a group of statisticians who
collaborate in basic, translational and clinical research. Areas of statistical expertise
include clinical trials; clinical epidemiology; genetic epidemiology; gene expression and
functional genomics; pharmacokinetic modeling; assays, bioassays, and diagnostics;
toxicology; and general statistical methods for data summary, inference and prediction.
Core members can help with study design, grant proposals, clinical protocols, data
analysis and manuscripts. Consulting generally consists of one or two meetings and is
without cost. The core can
provide HIPAA-compliant
identification of stored
tissue samples and medical
data meeting defined
characteristics. Statistical
Computing is provided in
conjunction with
collaboration.
• Chemical Good
Manufacturing Practices
(GMP) Synthesis Facility
(CGSF) is a state-of-the-
art manufacturing facility
for small and large molecule therapeutics for clinical trials. The CGSF provides services for
City of Hope Basic Research Handbook P a g e | 34

drug discovery, process research, development and early clinical manufacturing of


pharmaceutical drug substances (APIs) that meet Food and Drug Administration (FDA)
requirements. With its significant capabilities, the CGSF plays a key role in bridging basic
science and translational medicine at City of Hope.
• Clinical Immunobiology Correlative Studies Laboratory (CICSL) has developed and
has available a variety of assays that are based on molecular, functional and biochemical
platforms. The laboratory operates under principles of Good Laboratory Practices (GLP)
to support clinical trial protocols in the Cancer Center. Request service using iLAB.
• Cytogenetics Core Laboratory provides classic and molecular cytogenetics [fluorescence
in-situ hybridization (FISH)] services to Beckman Research Institute investigators, as well
as non-City of Hope investigators. FISH testing has proved invaluable as a diagnostic tool
in many types of malignancies and is useful in determining both prognosis and course of
treatment. The equipment in the Cytogenetics Core Laboratory is available to
investigators on an appointment basis. The laboratory also provides training and
consultation services in molecular cytogenetic testing.
• Design and Fabrication Lab provides the COH medical and research community with
design and fabrication services, including mechanical and 3D design, electronic and optical
design, and instrument modification. This core works with simple devices like radiation
shields and electrophoresis units, to fully automated, computer-controlled instruments
such as sequencers and synthesizers. Fabricating services cover all basic machine
operations such as turning, CNC milling, drilling and sheet metal forming. Request service
using iLAB.
• Drug Discovery and Structural Biology Core (DDSB) was established to provide the
necessary technical and scientific resources to facilitate drug discovery efforts consistent
with the cancer center’s translational research goals. An important focus of the DDSB is
on cancer drug discovery in the area of molecular-targeted therapeutics, as well as
chemical biology probes. The core comprises four major service components that work
together in a complementary and cohesive manner to provide a full array of early-phase
drug discovery services and chemical probes for biological systems.
- DNA/RNA Peptide services include design and synthesis of highly specialized
siRNA-aptamers and DNA-peptide hybrid derivatives and peptides greater
than 100 amino acids in length.
- High Throughput Screening (HTS) assists investigators in identifying novel
lead compounds for anticancer drug development and chemical probes useful
for biochemical mechanistic studies via sophisticated high throughput
screening assays of synthetic compound and natural product libraries. A team
of medicinal chemists, pharmacologists, structural biologists, bioinformaticians
and clinicians help to optimize some of these small molecules for drug
development and translate them into clinical evaluation in cancer patients.
Request service using iLAB.
- Synthetic and Biopolymer Chemistry Core (SBCC) provides both biopolymer
and small-molecule synthetic services to scientists at City of Hope.
City of Hope Basic Research Handbook P a g e | 35

- X-ray Crystallography Core Facility provides structural information to


understand mechanisms of biological systems at the atomic level, validates
binding sites of lead compounds of therapeutic interest, and facilitate leads
discovery through co-crystallization of therapeutic targets and small molecule
libraries. Request service using iLAB.
• Electron Microscopy Core provides equipment to define ultrastructural details in their
experimental systems. The EM Core assists with all aspects of studies brought to the lab
including training, experimental
design and interpretation of
results. A variety of preparation
methods are available for
transmission and scanning
electron microscopy including
ultra-thin sections of
conventionally fixed samples,
immunogold labeling, plunge-
freezing cryo-EM and
tomography. Request service
using iLAB.
• Integrative Genomics Core
provides high quality, efficient,
comprehensive and cost effective services using microarray and high-throughput
sequencing technologies as well as basic and advanced data analysis services to make
complex data biologically interpretable for clinical and basic investigators. Request
service using iLAB.
- DNA Sequencing/Next Gen Sequencing provides convenient, rapid and cost
effective DNA analysis for all investigators. The laboratory is equipped with
state-of-the-art Illumina Genome Analyzer II systems, including a Cluster
station and a Paired-end module. The core also has a state-of-the-art Hitachi
AB model 3730 48-capillary DNA Analyzer with the capacity to analyze 4,000
to 8,000 samples per week.
- Microarray Core Facility provides microarray analysis of both DNA and RNA
samples, including transcript level expression, Exon level expression, miRNA
expression, transcription factor
binding, DNA methylation, and
histone modification.
• Light Microscopy Digital Imaging Core
provides widefield light microscopes,
confocal microscopes and makes available
the latest research platforms for
automated microscopy experiments,
advanced observation techniques and
sophisticated digital image processing and
analysis. Request service using iLAB.
City of Hope Basic Research Handbook P a g e | 36

• Mass Spectrometry and Proteomics provides high-quality mass analysis of biomolecules


– proteins, glycoproteins, peptides, oligonucleotides, nucleic acids, lipids and small-
molecule metabolites – for a variety of biomedical investigations. The facility offers
supporting techniques as well as scientific consultation. Request service using iLAB.
• Nuclear Magnetic Resonance (NMR) Core applies high resolution NMR spectroscopy to
the structural characterization of biomolecules, small organic compounds, natural
products and biomolecular complexes, including protein-protein, protein-nucleic acid and
protein-ligand complexes.
• Pathology Core provides access to optimally preserved tumors and normal tissues. Over
ten thousand samples of diverse neoplasms are currently available in the frozen tumor
bank, along with many samples of normal tissue. Periodic inventories and sample testing
are conducted to ensure quality of preserving DNA/RNA/protein integrity. All entries are
recorded in a computerized database in the tumor bank.
• Small Animal Imaging Core (SAIC) provides equipment for optical bioluminescence
imaging, fluorescence imaging, gamma camera, PET scanner and CT scanner to allow non-
invasive monitoring of the dynamic biodistribution of therapeutic agents as well as vital
processes such as gene expression, cell trafficking, cell viability, cell proliferation, tissue
hypoxia and angiogenesis in the intact animal. Request service using iLAB.
• Survey Research Core (SRC) provides a wide range of services in the areas of study
design and sampling, survey instrument development and evaluation, data coding,
collection, management, analysis and reporting. Request service using iLAB.
• Translational Biomarker Discovery Core is currently under development. Request
service using iLAB.
• Translational Research Laboratory (TRL) supports basic science investigators, clinical
investigators, population investigators and clinical science collaborations to ensure the
inclusion of scientifically sound correlative studies in clinical trials and to enable and assist
research studies using clinical samples from clinical trials.

LIBRARY SERVICES
What Our Purpose Is

The Department of Library Services serves the information needs of the City of Hope community,
supporting the institution’s clinical, scientific and educational missions.

How We’re Organized

• Call: Extension 68497


• E-mail: [email protected],
• Website: http://www.cityofhope.org/library
• Location: Lee Graff Medical and Scientific Library
• Hours: Monday - Friday 8 a.m. - 6 p.m.
City of Hope Basic Research Handbook P a g e | 37

What We Do

For the basic investigator, the library offers:

Expert Help Finding and Managing Information and Complying with Funder Requirements

• One-on-one consultations to help find relevant information to support research as well as


strategies for keeping up with new developments in the investigator’s field.
• Assistance with managing information and publishing research: using EndNote to manage
citations, finding the right journal for the publishing the research paper, evaluating and
increasing the impact
of the research
• Customized classes
for the investigator
and research team on
a variety of topics.
• Support for grant
reporting and
compliance with the
National Institutes of
Health (NIH) Public
Access Policy: help
setting up My NCBI
My Bibliography,
submitting and
tracking publications
through the NIH PAP
workflow and generating lists of publications for grant progress reports.

Databases, Journals, Books and Historical Materials

• Databases in a variety of scientific fields


• A customized version of PubMed with links to full text from the library’s collections and
commonly used filters for limiting searches
• An extensive collection of journals, most available electronically
• An extensive collection of books, many available electronically
• The Career and Professional Development Collection, featuring print and electronic books
on grant writing, lab management, developing CVs, giving presentations and more
• 24/7/365 access to databases and electronic books and journals from any computer
anywhere via VPN
• Interlibrary loan and document delivery service to deliver articles and book chapters
directly to the investigator, either from City of Hope collections or from other libraries.
• The City of Hope Archives, which can supply historical photos and other materials.
City of Hope Basic Research Handbook P a g e | 38

Space to Read, Work and Relax:

• 24/7/365 access to the Lee Graff Medical and Scientific Library, which offers quiet study
and relaxation space as well as print books and journals, computers, and two walking
stations to exercise while reading/working.

CREATIVE SERVICES
What Our Purpose Is

Creative Services is the resource for designing research presentations.

How We’re Organized

• Call: Extension 26384 or Extension 62447 for Design and Photography


• Call: Extension 65080 for Print Services
• E-mail: #[email protected] subject line “Design – New Users” to register as a new user to
receive log-in information for the “Instant Web Publishing” request site accessible from
the Creative Services website
• Website: http://www.coh.org/creative-services/Pages/default.aspx

What We Do

Areas of expertise include


conceptualization, graphic design,
typography, photography and
production. Creative Services maintains
electronic templates for both internal
and external scientific meeting and
conference presentations as well as
templates for research posters of varying
dimensions. Turnaround time is usually
three to five business days for basic jobs
and up to two weeks for larger projects.
Events require one to two months’ lead-
time depending upon complexity of
elements.

The following tools are available on the Creative Services Intranet page:

• Research poster templates


• City of Hope branding style guides
• Writing style cheat sheets
City of Hope Basic Research Handbook P a g e | 39

GRANTS MANAGEMENT
As a first step, investigators should discuss their project with their
department chair and determine what resources are needed.
Investigators who are knowledgeable about what internal support may be
available are in a better position to seek external support.

This section describes the services and procedures of offices that help
investigators identify, apply for and manage grants as well as other types
of agreements related to basic research. The following chart identifies
the offices that help administer and provide support to investigators and
their research and administrative staff. These offices work closely
together to determine the appropriate City of Hope office to administer
the funding, contract and/or licensing aspects of a project and provide
assistance to investigators and department administrative staff.

All research, scholarly activities and projects funded in whole or in part


Office of Sponsored
by a governmental agency (federal, state or local) are processed through
Research (OSR)
the Office of Sponsored Research (OSR).
Research, scholarly activities or projects supported by individuals or
Office of Foundation
private foundations are administered through the Office of Foundation
Relations (OFR)
Relations (OFR).
Office of Faculty and Assistance in finding grant funding opportunities, writing proposals and
Institutional Support editing manuscripts is provided by the Office of Faculty and Institutional
(OFIS) Support (OFIS).
Negotiation of non-disclosure agreements (NDAs), confidential
disclosure agreements (CDAs), material transfer agreements (MTAs)
Office of Technology
and licensing of intellectual property and facilitation of collaborations
Licensing (OTL)
between City of Hope and outside institutions and industry is provided
by the Office of Technology Licensing (OTL).
Business Managers/Directors deal directly with Grant Accounting on
Grant Accounting behalf of investigators as far as invoicing, adding chart of accounts and
financial reporting required by several agencies.
Oversight and management of expenditures of research institutional
Research Finance budgets and discretionary cost centers is the responsibility of the
Research Finance Department.
City of Hope Basic Research Handbook P a g e | 40

OFFICE OF SPONSORED RESEARCH


What Our Purpose Is

The Office of Sponsored Research (OSR) provides the necessary support to improve the
effectiveness of sponsored programs and ensure that grants and contracts comply with City of
Hope’s standards for academic freedom, research ethics and fiscal responsibility.

OSR is the central administrative office responsible for submitting proposals and accepting awards
on behalf of City of Hope. Sponsored project proposals may only be submitted, and awards accepted,
by individuals authorized in OSR to sign the necessary documents. Investigators and administrative
staff are not authorized to submit proposals, accept grants or execute contracts on behalf of City of
Hope.

How We’re Organized

The Office of Sponsored Research (OSR) is under Basic Research Operations.

• Call: For contact information, see: http://www.coh.org/OSR/Pages/contact-us.aspx


• E-mail: [email protected]
• Website: For OSR assignments by administrator, business manager/director or
department; forms; policies and procedures, see:
http://www.coh.org/OSR/Pages/default.aspx .
• Grants Calendar: http://www.coh.org/grants-calendar/Pages/default.aspx

What We Do

OSR supports research faculty and staff by providing pre-award and post-award grant administration.
OSR liaises with grant sponsors on behalf of investigators and acts internally as the intermediary
between the Office of Foundation Relations, Office of Technology Licensing, Grant Accounting, Legal
Office, Corporate Compliance Office and auditors, both internal and external. OSR staff assist
investigators by reviewing grant proposals to ensure compliance with sponsors’ terms and
conditions, as well as, City of Hope policy and federal regulations and requirements.

OSR responsibilities include, but are not limited to:

• Acts as the liaison between City of Hope and extramural sponsors

• Provides guidance to faculty and staff regarding proposal preparation


− Assists with the review of the proposal content and format
− Assists with the review of the application forms

• Reviews and endorses all proposals to extramural sponsors


− Institutional review focuses on commitment of institutional resources and compliance
with City of Hope and sponsor policies
City of Hope Basic Research Handbook P a g e | 41

• Reviews award terms and conditions and accepts on behalf of City of Hope and
investigator by approving budget and requesting the appropriate Project ID(s)

• Coordinates sponsor requests for additional information


− Just-in-Time requests
− Administrative Supplements
− Change in SOW
− Changes in key personnel
− No-cost extensions
− Budget revisions
− Requests to carry forward funding from one year to the next

• Ensures compliance with relevant City of Hope policies and procedures governing the
conduct of research and other extramural activities, including:
− Protection of human and animal subjects (IRB and IACUC)
− Use of City of Hope facilities and appropriateness of the research activity
− Adherence to personnel policies and compensation plans
− Technology Transfer
− Conflicts of Interest
− Recovery of direct and indirect costs
− Liability insurance and indemnification/medical malpractice coverage

Transferring A Grant From Another Institution

To transfer a grant from the previous institution, contact the assigned OSR Grants and Contracts
Administrator. The transfer requires these actions:

1. Relinquishment: Investigator will inform the funding agency of their desire to transfer the
agreement to City of Hope. The grants office of the previous institution will inform NIH that it has
agreed to relinquish responsibility.
2. Proposal and Award to City of Hope: The investigator will need to prepare a proposal for the
remaining funds, following City of Hope proposal procedures. Business Manager/Director will
prepare PDAF for assignment of a GEMS number via RDMA. The OSR Grants and Contracts
Administrator will assist the investigator in submitting this proposal, along with any other letters
of support and other documentation, to the sponsor.
3. Transfer of Equipment: Based on sponsor approval, an agreement from the previous institution
to release equipment purchased on the grant to be transferred to City of Hope will be completed.
This is coordinated through Research Finance.

Applying for a New Grant

Sponsored Projects are externally funded research, scholarly activities or projects that have a defined
scope of work, deliverables or a set of specific objectives which provide a basis for sponsor
expectations, including, but not limited to financial reporting, specific project outcomes or intellectual
property rights.
City of Hope Basic Research Handbook P a g e | 42

1. Determining the Type of Project/Activity:

Term Definition
Basic: Research directed toward increasing knowledge of the subject
being studied. Includes activities that seek to increase the
understanding of fundamental phenomena.
Translational: Facilitates the translation of findings from basic science
to practical applications that enhance human health and well-being.
Research Basic research (bench-side) that can be directly applied to or closely
related to the patient care (bedside).
Clinical: Research that determines the safety and effectiveness of
medications, devices, diagnostic products and treatment regimens
intended for human use. These may be used for prevention,
treatment, diagnosis or for relieving symptoms of a disease.
Funding received in order to train or provide subsistence during
Research Training/
training, to either graduate students or post doctoral candidates
Fellowships
training in research techniques.
An agreement typically with a for-profit drug company (but not
Clinical Trials always) in which, with FDA approval, investigators are testing drugs,
devices or therapies on human subjects.
Typically funded purely to purchase equipment to enhance the
Equipment Grant
research infrastructure.
Funding received for a conference/scientific meeting. For a gathering,
symposium, seminar, scientific meeting, workshop or any other
Conference Grant organized, formal meeting where persons assemble to coordinate,
exchange, and disseminate information or to explore or clarify a
defined subject, problem, or area of knowledge.
Funding to help full-time faculty to attend regional, national, or
Travel Grant international professional affairs in order to present or perform
scholarly activities.
Instruction Given to develop or enhance curriculum.

2. Determining the Type of Application:

Term Definition
Refers to an application not previously proposed or one that has not
New Application
received prior funding.
A request for additional funding that is intended to extend, or results
Renewal (a.k.a. Competing
in the extension of, a project beyond the originally approved project
Continuation)
period.
City of Hope Basic Research Handbook P a g e | 43

Term Definition
Continuation The sponsor requires submission of a continuation or progress report
(Non-competing) in order that the sponsor can monitor the progress of a project with a
funding commitment of the entire project period.
(Progress Report)
A request for additional funds to support an existing project during
Supplement
that same project period.
A proposal submitted to make a significant change to a previously
Revision /Resubmission
submitted proposal not yet funded by the sponsor.

3. Determining the Type of Funding Mechanisms/Types of Award:

Term Definition
Gifts are contributions made to City of Hope for which the donor
receives nothing in exchange. Gifts may be restricted to a specific
purpose, or they may be unrestricted and used by City of Hope for any
Gifts purpose consistent with City of Hope’s mission and not-for-profit
status. Other than restricting the purpose of the gift, the donor may
not impose terms and conditions on the use of the gift funds or
require deliverables from City of Hope.
Grants are usually made in support of basic research, training, or
workshop support, requiring technical and financial reports rather
than specifying definite services or product deliverables. Grants
require City of Hope and its investigators to abide by certain terms
Grants
and conditions. Federal, state and local government agencies, for-
profit entities, and private not-for-profit organizations distribute
funding through grants, contracts and cooperative agreements, each
associated with terms and conditions.
Government agencies and for-profit, commercial entities may use a
procurement mechanism, such as a contract or purchase order, to
fund research or other programs of importance to the sponsoring
organization. Basically, one party is buying a service or product from
Contracts
the other in exchange for payment. Contracts assume the production
and delivery of a specific product that can be an instrument, device or
technical report. Consequently, contract requirements are more
specific and less flexible than grants.
Cooperative Agreements are an arrangement where both parties are
Cooperative Agreements involved in carrying out a portion of the research. Cooperative
agreements generally stipulate the responsibilities of both parties.
City of Hope Basic Research Handbook P a g e | 44

Term Definition
Subawards and Subcontracts are formal written agreements made
between a research institution that applies for the funding and City of
Hope that provides collaborators to perform a portion of the work.
Subawards and When funded by a grant or cooperative agreement, the applying
Subcontracts institution (Prime Recipient) will issue a Subaward to City of Hope
(Subawardee) providing funding from the prime award. If the prime
award is a contract, the award to City of Hope will be a Subcontract.
Applicable terms and conditions of the prime award will flow to City
of Hope.
Fellowships are awards of financial support to individually named
Fellowships students or postdoctoral scholars or to City of Hope on behalf of
individually named students or postdoctoral scholars. The funds are
treated as a research training grant, a type of sponsored research
project.

4. Identifying Funding Opportunities: The Office of Faculty and Institutional Support (OFIS) is
available to assist faculty and staff in locating potential external funding opportunities.

Federal Funding Sources (see: Grants.Gov)

• Department of Defense
• National Cancer Institute – Extramural Funding Opportunities
• National Institutes of Health – Office of Extramural Research
• National Science Foundation
• U.S. Army Medical Research and Material Command

State and Local Government Funding Sources:

• California Institute for Regenerative


Medicine
• University of California – Tobacco-
Related Disease Research Program
• University of California – California Breast
Cancer Research Program
• University of California – California
HIV/AIDS Research Program

Non-Federal Funding Sources:

• American Cancer Society


• Juvenile Diabetes Research Foundation
• Margaret E. Early Research Trust
• National Comprehensive Cancer Network
• Susan G. Komen for the Cure
City of Hope Basic Research Handbook P a g e | 45

Internal Funding Administrative Sources:

• Office of Foundation Relations – website posts grant opportunities from other groups
• Office of Faculty and Institutional Support – e-mails “Grant Bulletin” weekly
• City of Hope – Enhancement programs as announced via email

5. Obtaining A GEMS Number: A GEMS Number is required in order for OSR to maintain
organization of all proposals that enter the department. To obtain a GEMS Number, the following
steps should be followed at least 7 business days prior to the deadline:

Step 1 The investigator submits the following documents to [email protected]:


A. Proposal Data and Approval Form (PDAF)
1) Due to continuing updates/changes to the PDAF, it is highly recommended
that you download a new PDAF from the OSR forms page for every use.
2) Documents to assist in using the PDAF:
a. PDAF Signature Instructions
b. Assurance of Compliance
B. Abstract (Scope of Work)
C. Budget – Documents to assist in preparing the budget:
1) PHS 398 Face Page (Word Format)
2) PHS 398 Excel Spreadsheet with Consortium Calculation (For Internal Use
Only)
3) Percent Time and Effort to Person Months (PM) Conversion Table
4) Salary Cap Summary (Updated 2/9/2012)
D. Budget Justification
E. Facilities and Resources (If applicable)
F. Guidelines (If applicable)
G. PI Exception Form (If applicable)
H. IDC Waiver Form (if applicable)
Step 2 A confirmation email will be sent providing the assigned GEMS Number and identifying
the OSR Grants and Contracts Administrator who is responsible for future communication
regarding the proposal.
Step 3 After receiving a confirmation email, the final complete application is passed on to the
OSR Grants and Contracts Administrator for their review.

Filling Out Forms Related to Grants

Contact the OSR Grants and Contracts Administrator assigned to your department for assistance
with forms related to grants. Contact information can be found on the OSR website.
City of Hope Basic Research Handbook P a g e | 46

1. The Proposal Data and Approval Form (PDAF): The PDAF is used to identify key elements of
the proposal and to secure required signatures and, as appropriate, department approvals for use
of City of Hope resources. The PDAF form and instructions can be found on the OSR website.
2. Request for Approval to Spend Funds (RAS): The Director of the Office of Sponsored Research
must approve any budgetary commitment for pre-award costs on a new or competing grant
award. To obtain approval, the following steps should be followed:

Step 1 The Business Manager/Director of the Department/Division shall prepare a “Request for
Approval to Spend Funds” (RAS) and provide a line-item budget (not to exceed 25% of
the yearly budget requested in the proposal). Information provided on the RAS includes:
A. The GEMS Number that was assigned when the proposal was submitted.
B. Award specific information.
C. Requested budgetary amount.
D. Justification of need to incur costs prior to receipt of official notice of award.
E. Identification of a non-sponsored cost center for cost recovery if (1) the award is
ultimately not made or (2) the award start date is later than anticipated resulting
in expenses being incurred beyond the 90-day approved pre-award window.
Step 2 The following signatures are required:
A. Signature of the Department Business Manager/Director to acknowledge request
being made.
B. Signature of the investigator accepting responsibility for any expenses as a result
of the sponsor’s (1) failure to make the award entirely or (2) make the award with
a delayed start date.
C. Signature of the Division/Department Chair in recognition of the requested action
and, as necessary, provision of a non-sponsored activity cost center to guarantee
the financial risk where the investigator does not have sufficient discretionary
funds to guarantee the 90-day pre-award project expenses.
D. If neither the investigator nor the Division/Department Chair can provide
guarantee funds, the signature of the Director of BRI is required.
Step 3 The completed RAS form and supporting documentation (clearly scanned signed
documents) shall be submitted to the OSR Grants and Contracts Administrator for final
review and approval. The OSR Grants and Contracts Administrator will verify the
following with the sponsor:
A. That the sponsor will fund the grant or award a subcontract to City of Hope.
B. That in the case of City of Hope as Sub-recipient, verify that (1) Prime Recipient
has confirmed that the award will be made from the sponsor, and (2) the Prime
Recipient intends to award a subcontract to City of Hope.
C. The expected start date of the project.
D. The expected award amount.
E. The pre-award period that the sponsor recognizes.
F. That the sponsor allows pre-award costs.
City of Hope Basic Research Handbook P a g e | 47

Step 4 In addition, the OSR Grants and Contracts Administrator will:


A. Confirm that all institutional approvals are in place (as appropriate to the proposed
research), including:
1) PDAF is completed.
2) IRB protocol is approved, current and has received concordance review.
3) IACUC protocol is approved, current and has received concordance review.
4) COI review has been performed.
5) Other institutional reviews as required.
B. Review the requested budget to ensure it is 25% or less than the amount
requested in the proposal.
C. Verify the identification of a City of Hope or Medical Center non-sponsored
activity project for cost recovery if (1) the award ultimately is not made or (2) the
award start date is later than anticipated resulting in expenses being incurred
beyond the 90 day pre-award window.
D. Verify with the Business Manager/Director that adequate funds are available in
the alternate cost center.
E. Verify that the investigator has signed the RAS form indicating acceptance of
responsibility for pre-award costs if funding is (1) not subsequently awarded or (2)
the actual start date of the award is later than the anticipated start date, i.e.,
greater than 90 days from the pre-award approval date.
F. Verify that the Department/Division Chair has reviewed and signed the request
indicating his/her approval. If necessary, the Department/Division Chair has
provided a discretionary cost center as the financial guarantee.
Step 5 Upon approval of the Director of OSR and verification that conflicts of interest and
concordance reviews by the IRB and IACUC have been completed, the OSR Grants and
Contracts Administrator will prepare a “Project Costing Maintenance Form” and forward
it with the RAS and the requested line item budget to RDMA in order to establish a new
Project ID.
Step 6 Grant Accounting will establish the Project ID and forward the Grants File Maintenance
Form (GFM) to RDMA, who will inform the OSR Grants and Contracts Administrator.
Upon receipt of IRB and IACUC clearance, the OSR Grants and Contracts Administrator
will notify the investigator and the Department Business Manager/Director of the Project
ID.

Preparing Proposals

1. Once a faculty member has formulated an idea for a project and determined a potential sponsor,
the Department Business Manager/Director and OSR will assist the faculty member to ensure
that the proposal satisfies both the sponsor’s application guidelines and City of Hope’s
regulations.
2. A proposal requesting support from any sponsor will most often consist of the following
components:
City of Hope Basic Research Handbook P a g e | 48

Title Page For those sponsors that do not provide application packages or
have other specific requirements, the investigator must construct
some form of title page.
Table of Contents List of proposal sections including page numbers.
Abstract A brief description covering the purpose, important features and
significance of the project.
Research Plan A detailed description of the project.
Budget and Justification A reasonable estimate of the resources necessary to conduct the
project. Most sponsors require a detailed breakdown of the budget
into certain defined budget categories and a detailed budget
justification. The budget justification should clearly explain what
costs will be paid for by the sponsor and how the expense was
calculated.
Biosketches (CV) Biographical sketches for all key project personnel.
References List of all references cited in proposal.
Facilities and Resources If applicable.
Current and Pending If applicable.
Support
Appendices If applicable.

Submitting Proposals

1. Reviewing and Submitting the Proposal: OSR is the central administrative office responsible for
submitting proposals and accepting awards on behalf of City of Hope. Investigators and
departments should
allow adequate time
for proposal review.

Important: PDAF
should be submitted to
OSR seven to ten days
prior to the sponsor
deadline.

2. Processing a Paper
Proposal: The
following steps should
be followed when
processing a paper
proposal.
City of Hope Basic Research Handbook P a g e | 49

Step 1 The Departmental Administrator emails [email protected] to request an GEMS number and
includes the statement “This proposal will be a paper submission” along with the following:
1) Recipient
2) Address
3) Phone number
4) Date to be mailed
5) Dimensions and type of box
6) Estimated weight
7) Investigator
8) Department
9) Business Manager/Director
Step 2 When the department receives the assigned GEMS number, a copy will be sent to the OSR
Grants and Contracts Administrator.
Step 3 The day before the anticipated mailing date, the OSR Grants and Contracts Administrator
will prepare the FedEx mailing label and notify the department that it will be ready no later
than 9am the following day. The label will be saved as a PDF and emailed to the
department. The originating department is responsible for packing and mailing the grant.
Step 4 When preparing the shipping label, the OSR Grants and Contracts Administrator will
include the GEMS number, as well as, the department name and Business
Manager/Director in the reference field(s).

3. Processing an Electronic Proposal (Please refer to funding opportunity guidelines to


determine funding submission mechanism.)

• Grants.gov: A source to search for funding opportunities and to download application


packets. This website is used by OSR to apply for grants and track applications.
• eRA Commons: A new user who needs access to eRA Commons can obtain a username
by contacting RDMA. New users include, but are not limited to, investigators that transfer
to City of Hope from another institution.
• RPPR: A federally mandated reporting format for all federal grant agencies (NIH, NSF,
DoD, etc.) designed to provide consistent information on the progress of federally funded
research and research related activities.
• proposalCENTRAL: An e-grantmaking website shared by many government, non-profit
and private grant-making organizations.
City of Hope Basic Research Handbook P a g e | 50

Negotiating and Accepting Awards

1. Negotiating the Award: OSR is the central administrative office responsible for negotiating and
accepting awards on behalf of City of Hope. As needed, OSR consults with the investigator,
Department/Laboratory/Center Administrators and other administrative offices, such as the
Legal Department and Office of Technology Licensing.
2. Accepting the Award: A Notice of Grant Award, also known as NOGA, NGA, Sponsor Notice or
Award Letter, is the official notification from the sponsor indicating that a proposal has been
funded. Notice of Grant Awards are usually received by OSR, although in some circumstances,
investigators may be notified directly.
3. Setting-Up the Award Account: Prior to award setup, IRB and IACUC protocol approvals and
grant concordance reviews need to be completed, as well as all COI for key personnel identified
on a project. Otherwise, account set-up may be delayed. Upon receipt of a sponsor award notice
or update to an award, the OSR Grants
and Contracts Administrator initiates
the account set-up/modification
process by completing the PCMF. OSR
Grants and Contracts Administrator
sends the PCMF to Grant Accounting
to request a new or extend an existing
cost center number. Grant Accounting
sends confirmation of the account set-
up via a Grant File Maintenance (GFM).

Subawards (outgoing) are defined as


funding to an outside vendor under an
agreement received by City of Hope
which may include, but is not limited to,
the following:

• Account set-up: This should


occur at the time of the parent
grant’s PCMF
• Budget set-up
• Terms and Conditions
• Separate file for record keeping
• Subrecipient Commitment Form
• OSR Request Form

4. Entering Awarded Budgets and NOGA’s in GEMS and MediTract: The awarded budget is
entered into Grants Electronic Management System (GEMS) by the RDMA. This maintenance is
mandatory for all grants and contracts. Budgets will be entered according to their budget period
over the span of the awarded project period.

The budget entry, the notice of award, agreement, modifications to agreement and progress
report are entered into MediTract by the OSR staff.
City of Hope Basic Research Handbook P a g e | 51

5. Spending (Pre-award) Sponsored Funds: Many federal sponsors allow grantee institutions to
incur pre-award costs up to 90 days prior to the start date of a grant award. Any pre-award costs
the City of Hope incurs may not be reimbursed by the sponsor if an official award is not granted.
Therefore, such costs incurred during the pre-award phase of a grant are the financial risk of the
investigator and the institution. However, there is also a risk in making cost transfers onto a
sponsored project, when the cost center for that sponsored project has not been set up due to a
delay in receiving the official notice of award.

Look on the OSR website for information regarding the procedures and guidelines for obtaining
Pre-Award Spending Authorization (RAS).

The Director of Sponsored Research must approve any budgetary commitment for pre-award
costs on a new or competing grant award.

Grant Award Policies and Federal Regulations

City of Hope uses the following federal requirements in establishing procedures for administering all
awards for research and other sponsored agreements:

• NIH Grants Policy Statement


• OMB Circular A-122: Cost Principles for Nonprofit Organizations
• OMB Circular A-110: Uniform Administrative Requirements for Grants and Agreements
with Institutions of Higher Education, Hospitals, and Other non-Profit Organizations
• OMB Circular A-133: Audits of Institutions of Higher Education and Other Non-Profit
Institutions
• FAR: Federal Acquisition Regulations: Contracting Requirements

OFFICE OF FOUNDATION RELATIONS


What Our Purpose Is

The Office of Foundation Relations manages relationships with private philanthropic foundations to
advance City of Hope’s mission to conquer cancer, diabetes, HIV/AIDS and other life-threatening
diseases.

How We’re Organized

• Call: Extension 26224


• E-mail: [email protected]
• Website: http://www.coh.org/foundations/Pages/default.aspx
City of Hope Basic Research Handbook P a g e | 52

What We Do

The Office of Foundation Relations (OFR) works collaboratively with City of Hope investigators and
staff to ensure that communication with foundations is strategic and coordinated. Investigators need
to contact OFR before making any contact with private sources. Services include:

• Identifying, posting and alerting investigators via e-mail to foundation funding


opportunities and deadlines for proposal submission
• Communicating with potential funding agencies to discuss projects
• Assisting with proposal development and submission
• Planning and executing foundation site visits
• Monitoring award requirements
• Coordinating post-award
reports and stewardship

For investigators who come to OFR to


discuss their research interests, OFR
may:

• Put investigators in touch


with others at the
institution and elsewhere
who are involved in similar
projects or related
research
• Help identify, research and
qualify foundation
prospects for individual
projects
• Share knowledge about various foundations not available through or up-to-date on public
websites
• Assist investigators in strategizing their approach to foundations
• Work with investigators to determine the best initial contact with the foundation and who
at the institution needs to be involved
• Contact investigators when new foundation funding opportunities arise that dovetail with
their projects
• Consult with investigators on writing the proposal, preparing the budget and reporting
results

The following answers to some frequently asked questions provides an overview of the assistance
available through OFR.

What are some of the steps to finding the right foundation to fund a research project?

The Private Funding Opportunities webpage provide links to sites describing foundations that fund
the types of research conducted at City of Hope.
City of Hope Basic Research Handbook P a g e | 53

When considering possible donors, keep in mind the following:

• Foundations fund initiatives that align with their core mission and rarely make exceptions
to their pre-stated priorities. They typically have pre-determined programmatic and
geographic focus areas.
• Many foundations favor programs that are multi-institutional, interdisciplinary and/or
involve community partnerships.
• Many foundations provide funding opportunities to innovative or “risky” projects that are
ineligible for government funding.
• Foundations often prefer to support projects that will have an impact beyond the initiating
institution and/or projects that will develop new solutions to persistent problems.
• Many foundations provide support for a limited time (typically one to three
years). Therefore, foundations often want to see institutional support as well as plans to
secure additional funding after the foundation’s support is over.

What are some of the steps to writing a foundation proposal?

Each foundation has its own procedures and most maintain websites providing guidance to
applicants. Study these carefully, but contact OFR to ask for additional information that may not be
available or may not be up-to-date on these websites. Foundations want to bestow their grants
where the funds will yield the greatest results. In writing a proposal, investigators should consider:

• What is the problem to be addressed? Can the project be framed in the context of a larger
issue? What data demonstrates how the project will address that issue?
• Why is City of Hope the ideal institution to address this issue?
• Why is the foundation a good fit for the project?
• What qualifies the investigator to accomplish the research objectives?
• What key activities of the project will accomplish these objectives?
• What measurable outcomes will be used to evaluate success?
• What resources are needed in regard to time, money, facilities, and personnel?
• How will the project be sustained once the foundation’s funds have been expended?

What are RFPs and Limited Applications?

A Request for Proposals (RFP) is a foundation’s announcement inviting proposals for a specific
program or issue and providing a specific deadline. These RFPs may be released publicly or only sent
to pre-selected institutions identified by the foundation. OFR serves as a clearinghouse for many RFPs
and distributes them as appropriate within the institution. If an RFP limits the number of applicants
per institution, an internal scientific selection committee decides on the final candidate(s).
City of Hope Basic Research Handbook P a g e | 54

OFFICE OF FACULTY AND INSTITUTIONAL SUPPORT


What Our Purpose Is

The Office of Faculty and Institutional Support (OFIS) develops and supports an extramurally funded
research environment that assures integrity and compliance with appropriate regulations, and
facilitates communications among faculty and administrators.

How We’re Organized

• Call: Extension 62597 or 60277 to schedule scientific writing services

Please Note: Grant applications are given priority over manuscripts.

What We Do

Grant Bulletin

OFIS sends a weekly “Grant Bulletin”


e-mail to the Duarte campus listing
funding opportunities and
announcements from the National
Institutes of Health (NIH), other
government agencies and major
foundations. OFIS can also assist
investigators in locating potential
external funding opportunities.

Scientific Writing Services

The focus of Scientific Writing


Services is to provide free writing
and editing to investigators in writing
grant proposals and manuscripts. All
of the scientific writers have a
background (Ph.D.) in the biological
sciences. Investigators should
contact the scientific writers well in
advance of deadlines to ensure that
the writers can reserve adequate
time to provide assistance. Services
include:

• Reviewing grant proposals and manuscripts for grammar, consistency and the logical flow
of presented data
City of Hope Basic Research Handbook P a g e | 55

• Ensuring proposals are responsive to the purpose of a Request for Application (RFA) or
Request for Proposal (RFP) or to reviewer's comments in cases of resubmissions
• Reviewing response letters to editors/reviewers, abstracts, etc.

Documents are edited using the tracking tool in Word so that authors can easily accept/reject the
changes made.

OFFICE OF TECHNOLOGY LICENSING


What Our Purpose Is

The Office of Technology Licensing (OTL) protects faculty interests while advancing discoveries
toward commercial development.

How We’re Organized

• Call: Extension 65600


• E-mail: [email protected] to request a Material Transfer Agreement (MTA)
• Website: http://www.coh.org/otl/Pages/default.aspx

What We Do

Research at City of Hope often leads to important innovations or discoveries. Many times these
discoveries result in new inventions. These new inventions, while scientifically significant, may or
may not be considered “inventive.” Identifying which discovery or innovation is also an invention and
protecting them is the mission of the Office of Technology Licensing (OTL).

OTL handles non-disclosure agreements (NDAs), confidential disclosure agreements (CDAs),


material transfer agreements (MTAs) and licensing of intellectual property and provides input to
produce effective collaborations between City of Hope staff and outside institutions and industry.

OTL will assist the investigator to:

• Generate collaborations with industrial and academic partners


• Identify and protect intellectual property while preserving academic values
• Evaluate whether research results are patentable G
• Guide the investigator through the patenting process
• Effectively transfer discoveries and inventions from the laboratory into commercial
development
• Comply with City Of Hope policies and procedures as they relate to materials,
confidentiality and intellectual property, along with input from other teams at City of Hope
• Explore entrepreneurial and company start-up activities.
City of Hope Basic Research Handbook P a g e | 56

The following answers to some frequently asked questions provide an overview of the assistance
available through OTL.

What is intellectual property and who owns intellectual property developed at City of Hope?

“Intellectual property” includes inventions of new products, materials, designs, processes, methods,
techniques or algorithms, whether or not such inventions are actually patentable. Determination of
whether City of Hope will apply for a patent or protect the invention in another manner is performed
by OTL in consultation with the inventors. City of Hope owns intellectual property developed at City
of Hope. City of Hope intellectual property includes inventions conceived by those employed by, or
using resources owned by, City of Hope. This includes works that were developed under grants,
sponsored research or other agreements, or using City of Hope funds or facilities. Inventors must
formally give (“assign”) City of Hope the
rights and ownership (“title”) to all
inventions. Inventions made at any time
or place that are in anyway related to the
field of work for which you were
specifically hired for or is consistent with
the mission of City of Hope are
considered the property of City of Hope.
This includes inventions conceived or
developed at home or on weekends.

Who is covered by City of Hope’s


Intellectual Property Policy?

All investigators, scientists, physicians,


nurses, post-docs, students and others
working at City of Hope, including
everyone engaged in medical, scientific,
administrative or support work.
Everyone is subject to the City of Hope
Intellectual Property Agreement.
Creation of any invention while working
at City of Hope triggers three main obligations:

1. Disclosure — Inventor’s obligation to disclose to OTL any inventions


2. Cooperation — Inventor’s obligation to cooperate with OTL in the protection of the invention, for
example by a patent application(s)
3. Financial — City of Hope’s obligation to share royalties/income with the inventor(s)

What is a patent?

A patent is a property right granted by the government to “exclude others from making, using, selling
or importing the invention” in the country where the patent is issued. Companies wishing to practice
a patented City of Hope invention should seek a license from City of Hope to obtain suitable rights.
City of Hope Basic Research Handbook P a g e | 57

What can be patented?

There are three types of patents: utility patents, design patents and plant patents. City of Hope
inventions are primarily protected as utility patents. Utility patents are granted for any new material,
method, machine, manufacturing process or improvements to any existing inventions of these types.
At City of Hope, examples of patentable inventions include new molecules, methods of synthesis,
methods of use, assays, gene associations, protein interactions, screening methods, computer
algorithms, medical devices and drug formulations.

What makes an invention patentable?

For an invention to be patentable, it must be:

1. Novel — The invention must be a novel or new idea. An invention cannot be patented in the
United States if it has been described in a printed publication, has been in public use or offered for
sale in the US for more than one year before a patent application is filed. An invention cannot be
patented in any foreign country if it was described in a printed publication or has been in public
use at any time prior to submitting a patent application.
2. Non-obvious — The invention should not be obvious to a person having ordinary skill in the area
of technology at the time the invention was made. For example, the substitution of one material
for another is not patentable unless there is an unexpected effect.
3. Useful — The invention must have some useful effect or purpose.
4. Enabled — The invention must be clearly described so that a person of ordinary skill in the art can
make and use the invention. Occasionally this means demonstration of activity in an animal
model or human clinical trial.

Who are inventors?

• An inventor is a person who contributed to the “creative spark” — the conception — of an


invention. In some cases inventorship may require an intricate legal determination by City
of Hope’s patent attorney who is handling the case.
• A person who contributed only labor and/or the supervision of routine techniques, but
who did not contribute to the idea, is not considered an inventor.
• Inventorship is determined in accordance with US patent law. The criteria for inventorship
are different from that of authorship.

Are investigators always inventors?

Not necessarily. Inventorship comes from having, or meaningfully contributing to, the “creative
spark.” However, inventions often arise from or through close mentoring and discussions with
investigators. So, provided they meet all the requirements of inventorship, investigators can be co-
inventors.
City of Hope Basic Research Handbook P a g e | 58

What steps need to be followed to document research?

The following procedures are recommended to maintain good laboratory notebooks.

1. Use ink, not pencil when recording ideas and experiments.


2. Keep all records in bound notebooks with all pages numbered permanently in ink.
3. Keep lab notebooks intact and free from mutilation.
4. Make no erasures; cancel mistakes by drawing a line through them and writing the correct data in
the margin, with initials and the date after each such correction.
5. Make no changes or insertions on a page at any date later than that shown. If it is necessary to
make insertions, indicate by adding initialed and dated marginal note indicating when the change
and insertion are made.
6. Leave no blank pages between successive entries in the notebook. If a page or partial page is
skipped, draw lines through the unused portions with the
word "cancel," and add initials and date in the margin
along such areas.
7. Use the past tense of verbs to describe actions and
experiments that were actually completed.
8. Label ideas or proposals or suggestions as such so that
they may be differentiated from work actually performed.
9. State in detail how a proposed idea is to be carried into
actual practice. If the indicated method turns out to be
inoperative, then the record will prove only the conception
of a problem, not the conception of an invention.
10. Be explicit about what was actually done.
11. When using abbreviations or terms, make sure they are
"standard abbreviations or terms." Use of terms and
abbreviations should be explained in a table at the front or
back of the notebook.
12. Record all experiments contemporaneously with the
performance of the actual events. Do not use loose slips of
paper to record data for subsequent entries.
13. Sign and date each page of the notebook as it is
completed. For pages relating to ideas or laboratory work which may lead to important inventions,
be sure to have each such page witnessed and dated as soon as possible after completion of the
page.
14. In selecting a witness for the notebook, choose someone who is not likely to be an inventor or a
co-inventor but who will understand the experiment when it is explained and who is able to read
the relevant section in the notebook.

To document the invention, these steps should also be taken:

1. Try to preserve the "first samples" of new products or of products produced by a new method. To
each sample, attach a permanent label dated and signed and witnessed.
City of Hope Basic Research Handbook P a g e | 59

2. Whenever an experiment or apparatus is new, it would be very helpful to photograph the project.
All such photographs should be signed and dated and attached firmly to the relevant page of the
notebook.

Contact OTL with any questions regarding notebooks and other documentation of research.

When and how should an invention be disclosed to OTL?

Ideally, OTL should be contacted to discuss an invention after there is some evidence that it works
but prior to any public disclosure. Following discussion with OTL, may request submission of an
invention disclosure form. An invention disclosure should fully describe the invention and its
relevance so that OTL can properly assess its patentability and commercial potential and pursue
patent protection if applicable.

Allow at least 30 days prior to any public disclosure to ensure adequate time to review and prepare a
meaningful patent application.

When constitutes public disclosure of an invention?

Public disclosure may include:

• Oral or poster presentation at a scientific conference, to a company or to a non-federal


grant funding agency
• Publication of a manuscript or abstract
• Sharing detailed information with investigators from other institutions.

Does every invention disclosed to OTL result in a patent application?

No. The substantial expense of obtaining patent rights — roughly up to $25,000 for a US patent and
possibly over $100,000 for worldwide coverage — warrants critical examination of the commercial
potential of each invention disclosure.

What factors are used when deciding whether to file a patent?

If OTL determines the invention has potential commercial value and is adequately supported by
documentation from the inventors(s), City of Hope will initially file a provisional patent application in
the United States. Within eight to nine months after filing the provisional application, OTL will ask
the investigator for additional data that may have been generated since filing the provisional
application and review any commercial interest in the invention. Commercial value will be reassessed
as well as the likelihood the United States Patent and Trademark Office will allow a patent before a
decision is made whether to file a regular(non-provisional) US patent application. At that time, OTL
will also assess whether to file patent application(s) in foreign countries. Filing in foreign countries is
very expensive and is reserved only for intellectual property that is expected to result in significant
income for City of Hope or which is about to enter testing in clinical trials or is licensed to third
parties willing to bear the financial expense.
City of Hope Basic Research Handbook P a g e | 60

When will OTL start marketing an invention?

As soon as possible with the inventor’s help. The inventor’s professional contacts can be very useful
in bringing the technology to the attention of a commercial enterprise’s decision makers. The
inventor’s active involvement can dramatically improve the chances of success.

How can the inventor assist OTL in marketing an invention?

The inventor can help OTL staff identify candidate companies that have the expertise and resources
to bring the technology to the market. The inventor is asked not to approach companies without the
participation of OTL. If companies approach the
inventor, contact information should be obtained and
brought to the attention of OTL immediately. OTL will
coordinate the relationship and put in place a
confidentially agreement to ensure that any
confidential information is preserved. The inventor
may be asked to participate in telephone calls or
meetings with companies to help explain the invention
and its potential merits. OTL staff will help prepare the
inventor for these discussions.

What is a license?

Intellectual property can be licensed to other parties. A


license is a legal agreement, subject to federal, state
and local regulatory authorities, by which a patent
owner promises not to take action to exclude the
licensed party from making, using or selling a potential
invention. An exclusive license limits the use of the
invention to a single group or entity, while a
nonexclusive license allows for use by multiple
concerns. A license may be for patented, patent pending technology or for unpatented biological
materials. A license may be for patented, or patent pending technology, or for unpatented biological
materials.

A license is a contract between a company and City of Hope to grant rights in the intellectual
property to the company (licensee) in exchange for income for City of Hope. That income can include
cash license fees and a percentage royalty on any future sales of products. A license agreement can
be entered into with an established company or, under certain circumstances, with a new business
venture (a “start-up” company). City of Hope seeks licensees that can demonstrate a clear and
reasonable plan to make the technology broadly available in the marketplace. In every license
agreement, City of Hope always retains the right to continue using the licensed intellectual property
for internal research.
City of Hope Basic Research Handbook P a g e | 61

What do the inventors receive from a license agreement?

Under City of Hope’s Intellectual Property policy, City of Hope shares income from license
agreements with the relevant inventors. Inventors get a share of all licensing fees and royalties
received by City of Hope. Please review the City of Hope Intellectual Property Policy and contact
OTL for additional details.

Points to Remember

• If in any doubt, ask OTL about any request to enter into an agreement or provide a
signature
• If contacted by a commercial entity about your research, obtain contact information for
OTL to follow up
• Maintain good documentation of all research
• Talk to OTL in advance of any public disclosure (e.g., talk, poster, paper submission) if the
presentation includes important new scientific findings or ideas

RESEARCH FINANCE
What Our Purpose Is

The Research Finance Department is responsible for oversight and management of expenditures of
the research institutional budgets and discretionary cost centers (80/90/92/98).

How We’re Organized

• Call: Extension 62373


• Website: Forms and Applications used by Research Finance and other business entities
at City of Hope: http://www.coh.org/forms-and-applications/Pages/default.aspx

What We Do

The department collaborates with department administrators on annual budgets, identifies and
resolves budget variances and processes and tracks all research capital expenditures and investigator
recruitment packages. Additionally, the department manages the financial activities of the cancer
center support grant and the shared resource facilities.

The department reviews business expense reports, check requests, purchase requisitions, Human
Resources requisitions and hierarchy change requests for adherence to established City of Hope
policies and procedures.
City of Hope Basic Research Handbook P a g e | 62

Research Finance Orientation of Business Managers/Directors

The Research Finance Department provides training for new business managers/directors on the
policies and procedures, processes and systems available to assist with the management and
oversight of department financial activities. The business manager/director in the investigator’s
department is a good resource for navigating the requirements and processes under the purview of
the Research Finance Department.

Research Finance Policies, Procedures and Forms

The following forms, policies and procedures available via the City of Hope Intranet and are directly
related to the business performed within the Research Finance Department.

• Business Expense Report Forms / Business Expense Reimbursement Policy and


Procedures / Travel Policy and Procedures
• Business Manager/Director – Daily Period Range – All Years (Excel)
• Capital Expenditure Form
• Check Requests
• Contract
Management
• Hierarchy
Matrix
• Invoice
Approval
System
• International
Travel Request
Form
• Purchase
Requisition
System
• Virtual Account
Manager

Research Finance
Signature Requirements

Expense transactions against research institutional budget accounts or discretionary accounts (cost
centers beginning in 80/90/92/98) require additional approval by Research Finance. This
requirement is in addition to the hierarchy. Check Requests and Online Purchase Requisitions less
than $500 do not require additional approval from Research Finance. All expense reimbursements,
regardless of dollar amount, need Research Finance Approval.
City of Hope Basic Research Handbook P a g e | 63

COMPLIANCE

It is the policy of City of Hope to comply consistently and fully with


applicable federal and state laws and regulations and to conduct all of its
dealings ethically. This policy applies to all City of Hope Board members,
Medical and Allied Health Professional Staff members, personnel and
volunteers. This section covers some of the entities responsible for
providing guidance to investigators and staff to ensure compliance with
ethical and legal standards.
City of Hope Basic Research Handbook P a g e | 64

CORPORATE COMPLIANCE OFFICE


What Our Purpose Is

The Corporate Compliance Office coordinates City of Hope’s efforts to comply with the complex laws
and regulations governing health care and research activities.

How We’re Organized

The Compliance Program is directed by City of Hope’s Chief Compliance Officer, who is assisted by
Compliance Officers and a staff of associate or assistant compliance officers, managers and
assistants.

• Call: Extension 64205 Compliance Office


• Call: (877) COH-COH8/(877) 264-2648 Anonymous Compliance Hotline
• Website: http://www.coh.org/corporate-compliance/Pages/default.aspx

What We Do

In September 1999, City of Hope’s Board of Directors adopted City of Hope’s Corporate Compliance
Plan. This Plan is modeled after the US Department of Health and Human Services, Office of
Inspector General’s Compliance Program Guidance for Hospitals, which was initially issued in
February 1998 and updated with Supplemental Guidance in January 2005. The Corporate
Compliance Office is responsible for the implementation of the Plan and does so through City of
Hope’s Corporate Compliance Program entitled "A Matter of Integrity."

Key elements of “A Matter of Integrity” are found in the Code of Conduct, which is a summary of City
of Hope’s policies regarding ethical conduct and workplace behavior. It provides general guidance on
subjects of wide interest within City of Hope and is required to be reviewed upon hire and annually
thereafter as part of the performance evaluation process.

"A Matter of Integrity" includes an "open communication policy" which encourages personnel to
come forward with compliance questions and concerns. A variety of avenues are available for this
purpose, including an anonymous toll free compliance hotline. The Program also includes regular,
mandatory compliance training for all City of Hope Board members, personnel, investigators,
physicians and on-campus volunteers. The Program’s monitoring and auditing policy provides for
regular reviews of operations to assure regulatory compliance and to address any errors or the
possibility of any unethical or illegal conduct.

The Corporate Compliance Department is also assisted by the Corporate Compliance Committee
and its sub-committees, standing committees that meet regularly to assist in assuring the
effectiveness of the Compliance Program by ensuring that the objectives of the Program are reflected
in City of Hope governance, risk management, information management and financial and
operational activities.
City of Hope Basic Research Handbook P a g e | 65

Institutional Official

The Institutional Official (IO) is designated by City of Hope to ensure that research at City of Hope
has the resources and support necessary to comply with all federal and state laws and regulations
that govern research.

The IO is legally authorized to represent City of Hope in signing Assurances and assuming the
obligations of City of Hope under those assurances. IO is responsible for:

• Overseeing the research review boards and committees including:

− Institutional Animal Care and Use Committee (IACUC)


− Institutional Biosafety Committee (IBC)
− Institutional IND Quality Systems Committee (IIQSC)
− Institutional Review Board (IRB)
− Stem Cell Research Oversight Committee (SCRO)
− Radiation Safety Committee (RSC)

• Assuring that the research review board and committee members have the appropriate
knowledge to review research in accordance with ethical standards and applicable
regulations
• Assuring that all investigators have the appropriate knowledge to conduct research in
accordance with ethical standards and applicable regulations
• Facilitating investigator relationships with research components
• Overseeing the conduct of research performed by City of Hope’s investigators
• Overseeing the development and implementation of an educational plan for research
members, staff and investigators

Conflict Of Interest

As part of City of Hope's continuing efforts to identify and manage Conflicts of Commitment and
Conflicts of Interest, the Board of Directors has established the Conflict of Interest and Commitment
Committee (COICC). The COICC is an independent committee charged with serving as the
representative of the Board in preserving the independent decision-making of the governance,
operations and research mission of City of Hope pursuant to City of Hope COICC Policies.

RESEARCH PROTECTIONS
What Our Purpose is

Research Protections provides institutional oversight to ensure that all research at City of Hope is
ethical, scientifically justified, performed with appropriate safeguards for safety and privacy, and
conforms to Federal and State laws and guidelines.
City of Hope Basic Research Handbook P a g e | 66

How We’re Organized

Research Protections oversees the activities of the following committees:

• Institutional Animal Care and Use Committee (IACUC)


- Call: Extension 80022
- E-mail: [email protected]
- Website: http://www.coh.org/iacuc/Pages/default.aspx
• Institutional Biosafety Committee (IBC)
- Call: Extension 83371
- E-mail: [email protected]
- Website: http://www.coh.org/ibc/Pages/default.aspx
• Occupational Safety and Biohazard Committee (OSBC)
- Call: Extension 83371
- E-mail: [email protected]
- Website: http://www.coh.org/osbc/Pages/default.aspx
• Stem Cell Research Oversight (SCRO) committee
- Call: Extension 83371
- E-mail: [email protected]
- Website: http://www.coh.org/scro/Pages/default.aspx
• Institutional Review Board (IRB)
- Call: Extension 82700
- E-mail: [email protected]
- Website: http://www.coh.org/irb/Pages/default.aspx

Research Protections also oversees three committees not covered in this handbook: the Cancer
Protocol and Review Monitoring Committee (CPRMC), the Protocol Review and Monitoring
Committee (PRMC), and the Data and Safety Monitoring Committee (DMSC).

What We Do

Depending on the proposed research activities, submission to and review and approval from more
than one committee may be required before work may commence.

Compliance Committee Submission Deadlines and Meeting Dates

Submission deadlines and meeting dates are listed on the Research Committees Calendar. Calendar
features include adding meetings to the investigator’s calendar and requesting e-mail reminders.

Compliance Committees Under Research Protections

Institutional Animal Care and Use Committee (IACUC)

The Institutional Animal Care and Use Committee (IACUC) is responsible for assuring that animal
research, testing, and/or training protocols conducted at City of Hope involving live, vertebrate
City of Hope Basic Research Handbook P a g e | 67

animals are ethical, humane, scientifically justified and have the potential for advancement of science,
medical knowledge and/or animal health.

The IACUC is also responsible for assuring that the City of Hope Institutional Animal Care and Use
Program for the procurement, housing, and care and use of animals maintains full accreditation with
the Association for the Assessment and Accreditation of Laboratory Animal Care International
(AAALAC) and conforms to the Institute for Laboratory Animal Research (ILAR) Guide for the Care
and Use of Laboratory Animals; all regulations of the United States Department of Agriculture
(USDA) which implement the Animal Welfare Act (AWA) of 1966 and its amendments (9 CFR,
Chapters 1, 2, 3); and the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory
Animals.

Investigators are required to secure IACUC approval prior to initiating research involving live animals.

IACUC Training Required: Regardless of previous training/work experience, all personnel listed on
an IACUC protocol must complete the mandatory IACUC Animal User Training Program:

1. CITI Online courses

• Investigators, Staff and Students (if listed on an IACUC protocol)


• Reducing Pain and Distress in Laboratory Mice and Rats (if listed on an IACUC protocol)
• Aseptic Surgery (if working with live animals)
• Working with Mice in Research (if working with mice)
• Working with Rats in Research Settings (if working with rats)
• Working with the IACUC-Refresher (at 3 year anniversary of completing CITI courses)

2. Introduction to City of Hope and Beckman Research Institute Animal Care and Use Program (if
listed on an IACUC protocol)

3. Hands-on training sessions provided by the Animal Resource Center (ARC)

• Rodent Handling Restraint and Biomethodology (if working with rats or mice)
• Rodent Aseptic Surgical Technique and Anesthesia (if working with rats or mice)
• Rodent Survival Surgery Training (if conducting survival surgery)

IACUC Submission Process: All projects that include research activities under IACUC purview
must be submitted through the Integrated Research Information Systems (iRIS). iRIS is the electronic
system utilized by the IACUC to assist in the review and management of research projects.

Submissions must be made for:

• New Protocols
• Amendments to Ongoing Protocols, including changes in personnel
• Annual Continuing Review
• 3rd year Renewals (every 3rd year, the entire protocol is reviewed as if it were new)
• Unanticipated Problems
• Closures
City of Hope Basic Research Handbook P a g e | 68

IACUC Review Process: Once received, an IACUC protocol submission may require multiple review
steps, including administrative review, attending veterinarian pre-review, assigned primary reviewer’s
review and full committee review. Therefore, requests for submission of annual continuing reviews
and 3rd year renewals should be addressed promptly to allow sufficient time for the submission
process from review to approval.

At a convened meeting of a quorum of the members, the IACUC will review the submission and take
one of four possible actions: (1) Approved/
Approved with Comments; (2) Approval
pending the conditions are met; (3) Deferred;
(4) Disapproved. All IACUC review outcomes
will be sent in writing to the investigator.

Lack of a prompt response to IACUC


conditions will delay approval of new
protocols or amendments. Lack of a prompt
response to conditions regarding annual
continuing review or 3rd year renewal that
cause a delay in re-approval past the
expiration of the previous approval will result
in closure of the protocol. If the protocol is
closed, no animal work described in the
protocol will be permitted.

Investigators with approved IACUC protocols


are responsible for the following:

1. To make sure that all research staff


involved in the conduct of the animal
research project have read, and have a
clear understanding of, the IACUC approved protocol procedures and requirements.
2. To obtain IACUC approval prior to initiating any changes in the protocol. (No changes can be
initiated until IACUC approval has been secured.)
3. To report to the IACUC any unexpected problems involving animals as soon as the investigator is
aware of them.
4. If concordance review of an associated grant application is required, to contact the Director of
Office of Laboratory Research Subjects Protection.

Institutional Biosafety Committee (IBC)

The Institutional Biosafety Committee (IBC) is responsible for review of all research involving the use
of recombinant or synthetic nucleic acid molecules (i.e., DNA, RNA) , including the use of transgenic
animals and plants. The IBC ensures all such research conducted at or sponsored by City of Hope is
conducted in accordance with NIH Guidelines for Research Involving Recombinant or Synthetic
Nucleic Acid Molecules regardless of funding source.
City of Hope Basic Research Handbook P a g e | 69

General responsibilities include review of research projects for compliance with NIH Guidelines in
areas such as physical and/or biological containment levels, facilities, procedures, practices, training
and expertise of personnel, as well as, institutional procedures and practices.

IBC Training Required: City of Hope does not offer any specific courses regarding use of recombinant
or synthetic nucleic acid molecules. Investigators completing IBC Protocol Review Forms will be asked
to provide a summary of experience and
training of all personnel to demonstrate that
the research team includes personnel with
competency to safely perform the work
described in the protocol.

IBC Submission Process: All research


projects that include research activities
under the purview of the IBC must be
submitted to the IBC according to the
submission requirements and using the
Word protocol review forms posted on the
IntraNet.

Prior to completing the IBC Protocol Review


Form for a new research project, send an
email to [email protected] to obtain an IBC protocol number. Include the assigned protocol
number where indicated in the IBC Protocol Review Form.

Submissions must be made for:

• New Protocols
• Amendments to Ongoing Protocols, including changes in personnel
• Annual Continuing Review
• 3rd year Renewals (every third year the IACUC reviews the entire protocol as if it were a
new project)
• Unanticipated Problems
• Closures

IBC Review Process: Investigators are required to secure IBC approval prior to experimentation
using recombinant DNA materials and ordering or transport of genetically altered cells or materials
that fall in the category of requiring IBC approval (review categories III-A, III-B, III-C and III-D). The
IBC Protocol Review Form must be completed and submitted for research falling into categories III-E
and III-F, but experiments may be initiated after the form has been submitted prior to receiving an
acknowledgement from the IBC.
City of Hope Basic Research Handbook P a g e | 70

Experiments that Require Institutional Biosafety Committee (IBC) Approval, Institutional


Review Board (IRB) Approval, NIH Recombinant DNA Advisory Committee (RAC) Review,
III-A and NIH Director Approval Before Initiation. Example of experiments are (1) Deliberate
transfer of a drug resistance trait to microorganisms that are not known to acquire the trait
naturally.
Experiments that Require NIH/OBA (Office of Biotechnology Activities) and IBC Approval
III-B Before Initiation. Example of experiments are (1) cloning of toxin molecules with LD50 of less
than 100 ng/kg.
Experiments that Require IBC, IRB Approvals and NIH/OBA Registration Before Initiation.
III-C Example of experiments are (1) Deliberate transfer of rDNA, DNA or RNA derived from
rDNA, into a human research participant.
Experiments that Require IBC Approval Before Initiation. Example of experiments are (1)
Using Risk Group 2 (RG2), RG3, RG4 or Restricted Agents as Host-Vector Systems (2) DNA
from RG 2, 3, 4 or Restricted organisms is cloned into nonpathogenic prokaryotic or lower
III-D eukaryotic host vector systems. (3) Use of infectious DNA or RNA viruses in tissue culture
(TC) systems. (4) Use of defective DNA or RNA viruses in presence of helper virus in TC
systems. (5) Experiments involving whole animals. (6) Experiments involving whole plants.
(7) Experiments involving 10 liters or more of culture.

III-E Experiments that Require IBC Notice Simultaneous with Initiation. Example of experiments
are (1) Experiments involving the formation of rDNA molecules containing less than 2/3 of
the genome of any eukaryotic virus.
Exempt Experiments. Example of experiments are (1) Experiments that use rDNA molecules
which are not conducted in organisms or viruses. (2) use of rDNA molecules that consist
entirely of DNA segments from a single nonchromosomal or viral source, one or more
III-F segments may be synthetic. (3) rDNA derived entirely from a prokaryotic host including
indigenous plasmids when propagated only in that host or closely related strain. (4) rDNA
that derives entirely from a eukaryotic host including indigenous chloroplasts, mitochondria,
plasmids but not viruses when propagated only in that host or closely related strain. (5)
Experiments using only synthesized small interfering RNA’s (siRNA) to study gene
expression.

At a convened meeting of a quorum of the members, the IBC will review the submission. The review
outcome may include conditions that the investigator will be required to address to secure approval.
For research in categories III-A through III-D, the IBC will take one of four possible actions: (1)
Approved/Approved with Comments; (2) Approved with Conditions; (3) Deferred; (4) Disapproved.
For research in categories III-E and III-F, the review outcome may be acknowledged or may include
conditions that the investigator will be required to address first. All IBC review outcomes will be sent
in writing to the investigator.

Lack of a prompt response to IBC conditions will delay approval of new protocols or amendments.
Lack of a prompt response to conditions regarding annual continuing reviews or 3rd year renewals
that delay re-approval past the expiration of the previous approval will result in closure of the
protocol. If the protocol is closed, no work involving recombinant DNA molecules described in the
protocol will be permitted.
City of Hope Basic Research Handbook P a g e | 71

Investigators with approved IBC protocols are responsible for informing the committee of any
unexpected problems related to recombinant DNA research as soon as they are aware of them and
not making any changes in review categories III-A through III-D until an amendment has been
submitted, reviewed and approved by the IBC.

Occupational Safety and Biohazard Committee (OSBC)

The Occupational Safety and Biohazards Committee (OSBC) is responsible for review of all research
involving the use of biohazardous materials (other than recombinant DNA under the purview of the
IBC and radioisotopes under the purview of the RSC), chemicals, carcinogens, infectious agents and
other safety hazards not covered by other institutional committees. The OSBC ensures that
appropriate safety precautions for the conduct of research using such materials are in place and
conform to regulatory and accrediting agency standards and guidelines.

Investigators are required to secure OSBC approval prior to conducting research activities under the
committee’s purview.

OSBC Training Required: Investigators completing


OSBC Protocol Review Forms will be asked to state
the number of years experience each personnel has
with the science described in the protocol. They will
also be asked to indicate each personnel’s training
status regarding the following:

• Hazardous Material Training


• Agent/Physical Specific
• Biosafety Level
• Bloodborne Pathogens
• Dangerous Goods Shipping

The research team must include personnel with the competency to safely perform the work described
in the protocol.

OSBC Submission Process: All research projects that include research activities under the purview
of the OSBC must be submitted to the OSBC according to the submission requirements and using the
Word protocol review forms posted on the IntraNet.

Prior to completing the OSBC Protocol Review Form, send an email to [email protected] to
obtain an OSBC protocol number. Include the assigned protocol number where indicated in the
OSBC Protocol Review Form.

Submissions must be made for:

• New Protocols
• Amendments to Ongoing Protocols, including changes in personnel
• Annual Continuing Review
City of Hope Basic Research Handbook P a g e | 72

• 3rd year Renewals (every third year the IACUC reviews the entire protocol as if it were a
new project)
• Unanticipated Problems
• Closures

OSBC Review Process: At a convened meeting of a quorum of the members, the OSBC will review
the submission. The review outcome may include conditions that the investigator will be required to
address to secure approval. The OSBC will take one of four possible actions: (1) Approved/Approved
with Comments; (2) Approved with Conditions; (3) Deferred; (4) Disapproved. All OSBC review
outcomes will be sent in writing to the investigator.

Lack of a prompt response to OSBC conditions will delay approval of new protocols or amendments.
Lack of a prompt response to conditions regarding annual continuing reviews or 3rd year renewals
that delay re-approval past the expiration of the previous approval will result in closure of the
protocol. If the protocol is closed, no work described in the protocol involving biohazardous materials
and other physical hazards can be performed.

Investigators with approved protocols are responsible for informing the OSBC of any unexpected
problems related to work described in the protocol as soon as they are aware of them and not making
any changes until an amendment has been submitted, reviewed and approved by the OSBC.

Stem Cell Research Oversight (SCRO) Committee

The Stem Cell Research Oversight (SCRO) committee is responsible for providing oversight of human
pluripotent stem cells and certain neuronal stem cell research activities. SCRO ensures that research
proposals involving human stem cells are ethical and scientifically justified, and that they conform to
California Institute for Regenerative Medicine (CIRM) Regulations regardless of funding source.

Investigators are required to secure SCRO approval prior to conducting research activities under the
committee’s purview.

SCRO Training Required: City of Hope does not offer any specific courses regarding use of stem cells.
Investigators completing SCRO Protocol Review Forms will be asked to provide a summary of
experience, training and qualifications of all personnel to demonstrate that the research team includes
personnel with competency to safely perform the work described in the protocol.

SCRO Submission Process: All research projects that include research activities under the purview
of the SCRO must be submitted to the SCRO through the Integrated Research Information Systems
(iRIS). iRIS is the electronic system utilized by the SCRO to assist in the review and management of
research projects.

Submissions must be made for:

• New Protocols
• Amendments to Ongoing Protocols, including changes in personnel
• Annual Continuing Review
City of Hope Basic Research Handbook P a g e | 73

• Unanticipated Problems
• Closures

SCRO Review Process: At a convened meeting of a quorum of the members, the SCRO will review
the submission. The review outcome may include conditions that the investigator will be required to
address to secure approval. The SCRO will take one of four possible actions: (1) Approved/Approved
with Comments; (2) Approved with Conditions; (3) Deferred; (4) Disapproved. All SCRO review
outcomes will be sent in writing to the investigator.

Lack of a prompt response to SCRO conditions will delay approval of new protocols or amendments.
Lack of a prompt response to conditions regarding Annual Continuing Review that delays re-approval
past the expiration of the previous approval will result in closure of the protocol. If the protocol is
closed, no work described in the protocol involving stem cells will be permitted.

Investigators with approved SCRO protocols are responsible for not making any changes until an
amendment has been submitted, reviewed and approved by the SCRO.

Institutional Review Board (IRB)

The City of Hope Institutional Review Board (IRB) is required to review and approve all research
projects involving human subjects prior to the initiation of research activity. The IRB ensures that
research proposals involving human subjects conform to federal Office of Human Research
Protections (OHRP) Title 45 Code of Federal Regulations Part 46, Food and Drug Administration
(FDA) Title 50 Code of Federal Regulations Part 21, and Health Information Portability and
Accountability Act (HIPAA) as applicable to research, regardless of funding source.

Investigators conducting projects involving human subjects are responsible for ensuring that
appropriate IRB approval is obtained and for complying with the requirements of City of Hope
policies and procedures governing human subjects research.

Human Subjects Research Training Required: Prior to participating in any research project
involving human subjects, all key personnel are required to complete the training courses listed
below. Failure to complete any of the training courses will result in the inability to participate in
research studies involving human subjects and/or a possible delay in the approval of a submission.
Please note that courses can be completed in parallel with completing the IRB application.

1. Clinical Research Certification Training (CRC)

The CRC gives an overview of basic human subject principles and must be completed and
renewed every 3 years to continue conducting research involving human subjects. For
instructions on completing this training, visit the Clinical Research Training Office Intranet site.

2. Adverse Event and Unexpected Problem (AE/UP) Training

This course provides an overview of City of Hope’s policy regarding reporting of adverse events
and unanticipated problems. This training is completed once and does not require renewal.
City of Hope Basic Research Handbook P a g e | 74

IRB Submission Process: All research projects that include research activities under the purview of
the IRB must be submitted to the IRB through the Integrated Research Information Systems (iRIS).
iRIS is the electronic system utilized by the IRB to assist in the review and management of research
projects.

Submissions must be made for:

• New Protocols
• Amendments to Ongoing Protocols, including changes in personnel
• Annual Continuing Review
• 5th Year Renewals (every third year the IRB reviews the entire protocol as if it were a new
project)
• Unanticipated Problems
• Closures

IRB Review Process: The IRB review process is generally separated into four processes. For basic
science investigators, the most common review processes used will generally be non-human
subjects, exempt and expedited.

The diagrams below illustrates the IRB workflow of a submission through final approval:
City of Hope Basic Research Handbook P a g e | 75
City of Hope Basic Research Handbook P a g e | 76

Non Human Subjects Determination: In order for a project to require review by the IRB, it must meet
the definition of research and involve human subjects as defined by the Common Rule (45 CFR 46):

• Research means a systematic investigation, including research development, testing and


evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR
46.102(d)
• Human subject means a living individual about whom an investigator conducting research
obtains: (1) Data through intervention or interaction with the individual, or (2) Identifiable
private information. 45 CFR 46.102 (f)

To fall under Food and Drug Administration (FDA) regulations, projects must involve a regulated
FDA article, meet the definition of a clinical investigation and involve human subjects.

To determine if your project needs requires IRB review, use the decision tree below:

Exempt Review: Submissions meeting the exempt criteria do not need to be reviewed at a fully
convened IRB meeting. OHRSP is responsible for determining whether a submission qualifies for
exempt review. Common examples of research activities which may qualify for exempt review are:

• Research involving the collection or study of existing data, documents, records,


pathological specimens, or diagnostic specimens, if these sources are publicly available or
if the information is recorded by the investigator in such a manner that subjects cannot be
identified, directly or through identifiers linked to the subjects.
• Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior,
unless:
- information obtained is recorded in such a manner that human subjects can be
identified, directly or through identifiers linked to the subjects; and
- any disclosure of the human subjects’ responses outside the research could reasonably
place the subjects at risk of criminal or civil liability or be damaging to the subjects’
financial standing, employability, or reputation.

Expedited Review: Submissions meeting the expedited process criteria do not need to be reviewed at
a fully convened IRB meeting. OHRP is responsible for determining whether a submission qualifies for
expedited review. Common examples of research activities which may qualify for expedited are:

• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects,
the amounts drawn may not exceed 550 ml in an 8 week period and collection may not
occur more frequently than 2 times per week; or
- from other adults and children, considering the age, weight, and health of the subjects,
the collection procedure, the amount of blood to be collected, and the frequency with
which it will be collected. For these subjects, the amount drawn may not exceed the
lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more
frequently than 2 times per week.
City of Hope Basic Research Handbook P a g e | 77

• Prospective collection of biological specimens for research purposes by noninvasive


means. Examples include
- hair and nail clippings in a non-disfiguring manner;
- deciduous teeth at time of exfoliation or if routine patient care indicates a need for
extraction;
- permanent teeth if routine patient care indicates a need for extraction;
- excreta and external secretions (including sweat);
- uncannulated saliva collected either in an unstimulated fashion or stimulated
by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
- placenta removed at delivery;
- amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
- supra- and subgingival dental plaque and calculus, provided the collection procedure
is not more invasive than routine prophylactic scaling of the teeth and the process
is accomplished in accordance with accepted prophylactic techniques:

 mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth
washings.
 sputum collected after saline mist nebulization.

• Research involving materials (data, documents, records, or specimens) that have been
collected, or will be collected solely for nonresearch purposes (such as medical treatment
or diagnosis).

Waiver of Informed Consent and HIPAA Authorization: Examples of research studies that may qualify
for a waiver of informed consent and HIPAA authorization include retrospective chart reviews and
retrospective specimen collections. Any project requesting a waiver must meet these requirements:

• Waiver of Informed Consent: Federal regulations permit a waiver of informed consent when the
investigator can justify the waiver as meeting the following criteria outlined at 45 CFR
46.116(d) and 45 CFR 164.514(e):
- The research involves no more than minimal risk to the subjects.
- The waiver or alteration will not adversely affect the rights and welfare of the subjects.
- The research could not practicably be carried out without the waiver or alteration.
- Whenever appropriate, the subjects will be provided with additional information after
participation.

• Waiver of HIPAA Authorization: To qualify for waiver of HIPAA Authorization, investigators


must indicate:
- An adequate plan exists to protect protected health information (PHI) identifiers from
improper use and disclosure.
- An adequate plan exists to destroy those identifiers at the earliest opportunity, consistent
with the research, or as otherwise required by law.
- There is adequate written assurance that the PHI will not be reused or disclosed to any
other person or entity except as required by law; for authorized oversight of the research
project; or for other research for which the use or disclosure of the PHI is permitted by the
Privacy Rule.
City of Hope Basic Research Handbook P a g e | 78

Review of Use of Specimens from the City of Hope Biorepository: One of the main objectives of the
Pathology Core is to provide investigators access to optimally preserved tumors and normal tissues.
For information about how to use and draw down specimens from City of Hope’s Biorepository, see
the workflow on the following page. This workflow demonstrates how to navigate through the
regulatory systems at City of Hope and obtain specimens.
City of Hope Basic Research Handbook P a g e | 79

RADIATION SAFETY COMMITTEE (RSC)

The Radiation Safety Committee (RSC) is administrated by the Occupational Safety and Health
Department (OSHD). The RSC is responsible for review of all uses of radioactive materials at City of
Hope. This includes all radioactive material and radiation emitting machines and devices. The RSC
ensures that guidelines and practices are established for the protection of the health care and
research staff from radiation exposure that is consistent with keeping radiation exposure “as low as
reasonably achievable” (ALARA). The RSC also ensures the safety and comparable care for patients
receiving diagnostic and therapeutic doses of radioactive materials; and ensures the safety of visitors
and families of patients receiving therapeutic and diagnostic doses of sealed and unsealed radioactive
materials. These activities are conducted in accordance with Nuclear Regulatory Commission
Regulations at Title 10 Code of Federal Regulations Part 20, Title 17 of the California Code of
Regulations (CCR), the City of Hope Radioactive Materials License and the City of Hope Radiation
Safety Manual.

RSC Training Required: The State of California, in agreement with the Nuclear Regulatory
Commission (NRC), requires that every individual that works with radioactive materials receive initial
training on the protection and proper handling of isotopes and radiopharmaceuticals in their work
place, as well as annual refresher training.

The Radiation Safety Committee will suspend the Radioactive Material Use Permit where Authorized
Users or their Technical Staff are found to be delinquent in completing the annual refresher training
requirements following a 30 day grace period from the assigned date. The permit will be reinstated
once the Radiation Safety Committee has been provided with
appropriate documentation of training.

RSC Submission Process: All research projects that include


work under the purview of the RSC must be submitted to the
RSC according to the submission requirements and using the
Word forms posted on the Radiation Safety Forms Intranet
page.

Submissions must be made for:

• Non-human use of radioactive material


• Use of radioactive materials with animals
• Use of radiation-producing devices with animals
• Human use of radioactive material
• Facility use of radioactive material
• Machine use of radioactive material
• Amendments to previously approved uses

RSC Review Process: At a convened meeting of a quorum of the members, the RSC will review the
proposals and take one of four possible actions: (1) Approved/Approved with Comments; (2)
Approved with Restrictions or Recommendations; (3) Deferred; (4) Disapproved. All RSC actions
and reasons for their decisions will be sent in writing to the investigator.
City of Hope Basic Research Handbook P a g e | 80

ONGOING
City of Hope is committed to creating a great work environment. This
section covers additional resources for investigators to manage and enhance
their career at City of Hope.
City of Hope Basic Research Handbook P a g e | 81

OFFICE OF ACADEMIC AFFAIRS


What Our Purpose Is

The Office of Academic Affairs (OFA) is responsible for the management of academic activities in
the Beckman Research Institute and City of Hope Medical Center. This includes oversight of faculty
appointments, promotions, evaluation, recruitment and grievances. Policies and Procedures for
Academic Appointments and Promotions defines the policies and procedures for faculty, in terms of
appointments and promotions.

How We’re Organized

The Office of Academic Affairs (OFA) is an independent office under the direction of the Dean for
Faculty Affairs. The staff consists of the Program Manager assisted by an Academic Personnel
Coordinator and a Project Specialist.

• Call: Extension 62238, 60737 or 31252


• Website: http://www.coh.org/faculty-affairs/Pages/default.aspx
• Website: http://www.coh.org/faculty-senate/Pages/defaulty.aspx

What We Do

The OFA oversees the academic activities of the following appointment titles in one of three series
Assistant, Associate and Full:

• Professor
• Research Professor
• Clinical Professor
• Adjunct Faculty
• Visiting Faculty

The office oversees the activities of the following committees:

• Executive Committee of the Faculty Senate


• Full Senate or Members at Large
• Appointments and Promotions
• Nominating Committee
• Grievance Committee

The Faculty Senate consists of all members in the Professor, Research Professor and Clinical
Professor series. Senate members have voting rights and participate in the quarterly meetings and
functions as described in the Bylaws of the Faculty Senate of City of Hope.
City of Hope Basic Research Handbook P a g e | 82

FINDING ADDITIONAL LABORATORY PERSONNEL


Graduate School Students

Each first year student at the Irell & Manella Graduate School of Biological Sciences is required to
have a minimum of three lab rotations. The purposes of the rotations are (1) to help students find the
research area and lab in which they want to conduct their thesis research, (2) to learn experimental
techniques, and (3) to expose students to a broad
range of intellectual and technical approaches to
address current research challenges. Each lab
rotation is carried out in a different lab and lasts
from ten to twelve weeks. The student is expected
to spend a minimum of 20 to 25 hours per week in
the lab during a rotation. It is also expected that the
student perform at an exceptional level in advanced
coursework during this time and thus should be
allowed some leeway to study during weeks when
they have examinations.

Summer Students

City of Hope's
Eugene and Ruth Roberts Summer Student Academy
gives curious and hardworking students the
opportunity to learn about science by actually doing
it. Selected participants then spend 10 weeks
working full-time as a member of a biomedical
research team. Investigators serve as mentors who
guide students in their research, while helping them
develop their critical thinking skills.

Human Resources Hiring Department

A staffing need might come about as the result of personnel turnover, the creation of a new position,
or increased workload. Contact the Business Manager/Director prior to posting or hiring for a
position. The chart below provides an overview of the significant hiring process activities.
City of Hope Basic Research Handbook P a g e | 83
City of Hope Basic Research Handbook P a g e | 84

COMMUNICATIONS
What Our Purpose Is

City of Hope’s media relations team works with national, regional and local news media to inform the
public about the institution’s medical/scientific advances, events and other notable news.

How We’re Organized

City of Hope’s Communication Department falls under the Philanthropy and External Relations
Group. Investigators who have a newsworthy idea or who have been approached by the media are
asked to contact the media relations office.

• Contact: Extension 68215.


• Website: http://www.coh.org/communications/Pages/default.aspx

What We Do

Activities handled by media relations include:

• Writing and distributing press materials


• Media cultivation and outreach
• Coordinating live and taped media interviews with newspapers, news wires, television,
radio and Internet
• Management of campus photo and video shoots
• Fulfilling inquiries from news organizations
• Media and presentation training of faculty, other spokespeople
• Management and preparation of official statements on various topics (e.g., stem cell
research at City of Hope)
• Emergency communications (internal and external)
• Media monitoring, reporting and analysis
• Production of reprints, video/audio copies of news coverage
• Contributions to various City of Hope publications

Funding for research is getting more difficult to obtain, so communicating the research done at City
of Hope is important. Investigators who have news to share are asked to pass it on to the
communications team. They are interested in positive stories for City of Hope internal and external
publications, media outreach and social media channels.

For example, if an investigator is the first or senior author of a project that will be published, will be
speaking at a conference, has won an award or has an interesting personal story or intriguing
research story, the communications team would like to know about it.
City of Hope Basic Research Handbook P a g e | 85

EMPLOYEE HEALTH SERVICES


What Our Purpose Is

Employee Health Services (EHS) focuses on the health and safety of personnel related to the work
environment.

How We’re Organized

Employee Health Services (EHS) is under Human Resources (HR).

EHS Office and Clinic

• Location: Modular 90
• Hours: Monday – Friday 6:30 a.m. - 5:00 p.m.

Walk-In TB Clinic

• Location: Modular 90
• Hours: Mon, Tue, Wed, and Fri 6:30 a.m. - 10:00 a.m.

After Hours, Weekends and Holidays

• Location: The Evaluation Treatment Center located in Brawerman 1A provides first aid for
injured personnel.

Website: http://www.coh.org/hr/ehs/Pages/default.aspx

What We Do

Initial and Ongoing Health Screening

A brief physical examination, evaluation of immunization status and tuberculosis (TB) screening is
required before beginning work. An annual update consisting of a health questionnaire is required for
all personnel.

Immunization and Surveillance

All personnel whose workspace is located in a building that renders clinical services or who work in
the Animal Resource Center facility are required to maintain compliance with the City of Hope
Immunization Policy:

• Tuberculosis (TB) Surveillance Program – negative test of chest x-ray annually


• Rubeola (Measles) – evidence of vaccination or blood test proof of immunity
• Mumps – evidence of vaccination or blood test proof of immunity
• Rubella – evidence of vaccination or blood test proof of immunity
City of Hope Basic Research Handbook P a g e | 86

• Varicella (Chickenpox) – evidence of vaccination, blood test proof of immunity or


diagnosis or history of varicella or herpes-zoster disease documented by a health care
provider
• Tetanus, diphtheria and pertussis (TDAP) vaccine – current vaccine every ten years
• Influenza – vaccine is offered as available
• Meningococcal - personnel with anatomic or functional asplenia, persistent complement
component deficiencies or HIV infection should be vaccinated.
• Hepatitis B – Vaccine is offered to all personnel as indentified in the City of Hope Blood
Borne Pathogen Exposure Plan in the
Infection Control Manual - evidence of
vaccination or blood test proof of immunity

Individuals, who choose not to be vaccinated against


measles (rubeola), mumps, rubella, varicella, Tdap, or
meningococcol must sign the corresponding waiver
forms. Non-immune personnel who are occupationally
exposed to a vaccine-preventable disease may be
furloughed off work during the period of
communicability with pay. Other immunizations may
be offered to personnel by EHS which are not required
under the City of Hope Immunization Program. A
Tetanus diphtheria (Td) vaccine is offered to staff that
sustain a work-related laceration or puncture wound.

Work Related Injury or Illness

Any health issue that occurs on the job should be


reported as it occurs. EHS will assess the problem,
provide first aid and determine if further treatment is
needed.

Hazardous Chemical Exposure

Personnel are referred to EHS for evaluation, treatment and possible referral when they:

• Exhibit signs or experience symptoms associated with exposure to a hazardous chemical


in the laboratory
• Are exposed routinely above the action level or, in the absence of an action level, above
the Permissible Exposure Limit (PEL) for an OSHA regulated substance for which there is
exposure monitoring or medical surveillance requirements
• When a spill, leak, explosion, or other accident occurs in the work area that results in a
potential significant exposure to a hazardous chemical

If EHS is closed, staff is seen at the Evaluation and Treatment Center (ETC), a 24-hour, 7-day per
week urgent care clinic on the campus grounds. For more serious injuries beyond the scope of care
City of Hope Basic Research Handbook P a g e | 87

provided at EHS or ETC, an industrial clinic is available for staff to receive complete care. In emergent
situations 911 is called.

City of Hope provides the physician doing the medical evaluation or consultation with the following
required information:

• The identity of the hazardous chemical,


• Conditions under which the exposure occurred and
• A description of the signs and symptoms experienced by the worker.

This is accomplished through information provided in the Supervisor’s Report of Injury and additional
correspondence provided by the Occupational Safety and Health Department (OSHD).

City of Hope obtains the following required information from the physician after medical evaluation
or consultation:

• Any written opinion for a recommended follow-up examination, medical exam and the
attendant test results
• Any detected medical conditions of the personnel that might pose increased risk
• A statement that the personnel was informed of the medical examination/consultation results

City of Hope maintains for each personnel an accurate record of exposure monitoring results and any
medical consultation and examinations, including tests or physician medical opinions. Such records
must be kept, transferred and made available in accordance with OSHA’s rule governing access to
personnel exposure and medical records (29 CFR 1910.1020).

TRAVEL
Egencia Corporate Travel (through Expedia) is City of Hope’s exclusive travel management provider
for all business related travel including air, hotel, and rental car services for corporate travel. Travel
must be in the most economical and appropriate manner to meet the business objectives of City of
Hope. This includes the selection and use of City of Hope-preferred vendors. Air travel arrangements,
hotels and car rentals are to be made through the City of Hope Authorized Travel Agency. Any
exception to the following criteria will be identified for management’s consideration during the on-
line pre-trip approval process. All travel requests made through Egencia Corporate Travel will be sent
to the individual at City of Hope authorized to approve the individual’s travel.

City of Hope personnel and their eligible dependents may utilize the corporate travel program and
negotiated rates for personal travel. Personal travel requires a personal credit card payment at the
time of booking travel arrangement.

See the Intranet Travel site for current Travel Policies and Procedures, User Access Manuals and
Expedia Online User Manual.
City of Hope Basic Research Handbook P a g e | 88

CLOSING A LABORATORY
There are several steps and activities that are required when a person’s
employment with City of Hope/Beckman Research Institute ends. Some of
the items described are done by the departing personnel and other tasks are
accomplished for his/her administrator. All the applicable items must be
properly completed prior to withdrawal from active employment status. A
checklist is provided to use as a reference when departing from the City of
Hope/Beckman Research Institute.

This section is under development.


City of Hope Basic Research Handbook P a g e | 89

ACKNOWLEDGEMENTS

The Basic Research Handbook is the collective work of a diverse team of colleagues committed
to making the handbook user-friendly and responsive to the needs of investigators and their staff.

The BRH Working Group developed the format and provided most of the sections. The members
are Jocelyn Cumming, Business Director for Virology and Molecular & Cellular Biology, Nancy
Debretsion, Manager in the Office of Laboratory Research Subjects Protection, Rick Gulizia,
Director of the Office of Laboratory Research Subjects Protection, Janet Mendoza, Time and
Effort Administrator in the Office of Sponsored Research, Chuck Pickering, Director of Safety and
Occupational Health and Chief Safety Officer for the City of Hope, Frances Solano, Director of the
Office of Sponsored Research, and Noe Gonzales, Manager of Research Facilities and Emergency
Planning. Nancy Jenkins and Amy Stillings, who are no longer at City of Hope, contributed to
early drafts of the handbook.

The following individuals also wrote


sections or provided valuable
information: Ileana Abich, Academic
Personnel Program Manager, Janet
Crum, former Director of Library
Services, Mindy Dunkle, Contract
Management Systems Administrator,
Kenneth Golding, Animal Resources
Center Manager, Sharon Gonzalez,
Human Resources Coordinator,
Kimberly Hosozawa, Creative Services
Operations Manager, Christine Hui, IRB
Operations Director, Cathreen Johnson,
Employee Health Nurse Practitioner,
Stacy Kimmel, Director of Creative
Services, Shella Sarino-Gaor, Lead for
Immigration Services and Fausto
Velasco, Facilities and Logistics Support
Hub Consultant.

Creative Services and the Office of Technology Licensing provided photos and other images.
Kristen Santoni of Creative Services and Samuel Debretsion, as a volunteer, consulted on the
layout.

The following individuals reviewed the completed draft and recommended changes to the current
version: Ileana Abich, Jonathan Espenschied, Director of Graduate Medical Education and Clinical
Training, and Jeremy Jones, Assistant Professor in Molecular Pharmacology.
City of Hope Basic Research Handbook P a g e | 90

FEEDBACK

The Basic Research Handbook is intended to keep pace with changes in research at City of Hope
and in the needs of the research community.

If you have any comments, corrections and/or suggestions for additions and improvements, please
take a moment to e-mail feedback to Nancy Debretsion at [email protected].

Your input will help keep this handbook useful.

You might also like